Data / Medical devices / United States / Patterson Dental Supply, Inc.

Patterson Dental Supply, Inc.: FDA-registered device maker in St. Paul, MN, United States, 98 510(k) clearances

Name: Patterson Dental Supply, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Patterson Dental Supply, Inc. is registered with the FDA (registration 2183301) in St. Paul, MN, United States. It lists 141 device types. The FDA files 98 510(k) clearances under its listings, the newest dated June 21, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Patterson Dental Supply, Inc.

FDA registration number: 2183301
Address: 1031 Mendota Heights RD., St. Paul, MN, United States, 55120
Owner or operator: Patterson Companies, Inc. (9921026)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: December 30, 1983
Registered through: 2026
Brand names listed: 5-700;5-702;5801;5803;5804; CARB-EDGE; Carb-N-Sert; Integra; Jarit; Jarit Supercut; MicroFrance; Miltex; Padgett, ACCESSORY, SURGICAL APPAREL, Aura; Aura Bulk Fill; Aura eASY, BIO-C SEALER ION+, Bioactive Endosealer, Braval Saliva Ejectors, Braval Sodium Fluoride Varnish, Braval Sterilization Pouches and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Other Noble Metal	EJS	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Apron, Protective	IWO	1	Repackager or relabeler	accessdata.fda.gov
Articulators	EJP	1	Repackager or relabeler	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Repackager or relabeler	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Burnisher, Operative	EKJ	1	Repackager or relabeler	accessdata.fda.gov
Caliper	KTZ	1	Repackager or relabeler	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Repackager or relabeler	accessdata.fda.gov
Capsule, Dental, Amalgam	DZS	1	Repackager or relabeler	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Repackager or relabeler	accessdata.fda.gov
Carver, Dental Amalgam, Operative	EKH	1	Repackager or relabeler	accessdata.fda.gov
Carver, Wax, Dental	EIK	1	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Condenser, Amalgam And Foil, Operative	EKG	1	Repackager or relabeler	accessdata.fda.gov
Cord, Retraction	MVL	U	Repackager or relabeler	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Crown, Preformed	ELZ	1	Repackager or relabeler	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Repackager or relabeler	accessdata.fda.gov
Curette, Operative	EKE	1	Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Repackager or relabeler	accessdata.fda.gov
Dam, Rubber	EIE	1	Repackager or relabeler	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Repackager or relabeler	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Repackager or relabeler	accessdata.fda.gov
Detergent	JCB	1	Repackager or relabeler	accessdata.fda.gov
Device, Caries Detection	LFC	2	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Repackager or relabeler	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Repackager or relabeler	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Repackager or relabeler	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Repackager or relabeler	accessdata.fda.gov
File, Bone, Surgical	EMI	1	Repackager or relabeler	accessdata.fda.gov
File, Margin Finishing, Operative	EKA	1	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Repackager or relabeler	accessdata.fda.gov
Floss, Dental	JES	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Articulation Paper	EFK	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Rubber Dam Clamp	EJG	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gown, Examination	FME	1	Repackager or relabeler	accessdata.fda.gov
Gutta-Percha	EKM	1	Repackager or relabeler	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Headgear, Extraoral, Orthodontic	DZB	2	Repackager or relabeler	accessdata.fda.gov
Hemostat, Surgical	EMD	1	Repackager or relabeler	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Repackager or relabeler	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Repackager or relabeler	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Knife, Margin Finishing, Operative	EJZ	1	Repackager or relabeler	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Locator, Root Apex	LQY	U	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	1	Repackager or relabeler	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Repackager or relabeler	accessdata.fda.gov
Needle, Dental	DZM	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Paper, Articulation	EFH	1	Repackager or relabeler	accessdata.fda.gov
Pick, Massaging	JET	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Pliers, Operative	EJY	1	Repackager or relabeler	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Repackager or relabeler	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Repackager or relabeler	accessdata.fda.gov
Point, Silver, Endodontic	EKL	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Powder-Free Polychloroprene Patient Examination Glove	OPC	1	Repackager or relabeler	accessdata.fda.gov
Probe, Periodontic	EIX	1	Repackager or relabeler	accessdata.fda.gov
Processor, Radiographic-Film, Automatic, Dental	EGY	2	Repackager or relabeler	accessdata.fda.gov
Protector, Dental	BRW	1	Repackager or relabeler	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Collar And Crown	EIR	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Repackager or relabeler	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Dental)	EIB	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tube Impression And Matrix	KCQ	1	Repackager or relabeler	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Repackager or relabeler	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Repackager or relabeler	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Repackager or relabeler	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Repackager or relabeler	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Repackager or relabeler	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 21, 2024	K240862	Medicom Sterilization Wrap	FRG	Substantially Equivalent	Medicom Group, Inc.	accessdata.fda.gov
April 25, 2024	K233308	Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
May 24, 2023	K230106	General Cutting Straight	EGS	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
November 21, 2022	K221811	Vista BC Sealer	KIF	Substantially Equivalent	Inter-Med, Inc.	accessdata.fda.gov
November 17, 2022	K222518	FX Contra	EGS	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
November 1, 2022	K221478	Dolphin Blue Imaging	LLZ	Substantially Equivalent	Patterson Dental Supply, Inc.	accessdata.fda.gov
August 8, 2022	K222072	Dolphin Imaging 12.0	LLZ	Substantially Equivalent	Patterson Dental Supply, Inc.	accessdata.fda.gov
January 21, 2022	K213412	VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM	JOJ	Substantially Equivalent	Steris Corparation	accessdata.fda.gov
August 3, 2021	K211758	Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)	OPC	Substantially Equivalent	Hartalega NGC Sdn. Bhd.	accessdata.fda.gov
April 9, 2020	K200539	Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Public Company Limited	accessdata.fda.gov
March 20, 2020	K193581	Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Public Company Limited	accessdata.fda.gov
March 11, 2020	K193447	Vista Dyes	LFC	Substantially Equivalent	Inter-Med/Vista Dental Products	accessdata.fda.gov
March 4, 2020	K193389	Vista Clear	MVL	Substantially Equivalent	Inter-Med/Vista Dental Products	accessdata.fda.gov
December 12, 2019	K190537	BIO-C Sealer Ion+	KIF	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A	accessdata.fda.gov
August 2, 2019	K191741	Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape	JOJ	Substantially Equivalent	Intertape Polymer, Inc.	accessdata.fda.gov
May 30, 2019	K182308	Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Co., Ltd.	accessdata.fda.gov
April 22, 2019	K182778	LC GLOSSFILL XR	EBF	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaeten GmbH	accessdata.fda.gov
January 5, 2018	K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	EBC	Substantially Equivalent	Pulpdent Corporation	accessdata.fda.gov
February 23, 2017	K162926	Air-Powered Handpieces and Handpiece Attachments	EFB	Substantially Equivalent	W&H Dentalwerk Burmoos GmbH	accessdata.fda.gov
March 3, 2016	K151123	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film	PEM	Substantially Equivalent	Pac-Dent International, Inc.	accessdata.fda.gov
September 10, 2015	K151526	Zone, ZoneFree, Zone A1	EMA	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
January 7, 2015	K143486	Ufi Gel hard C	EBI	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 18, 2014	K133699	POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES	LZA	Substantially Equivalent	Pt. Smartglove Indonesia	accessdata.fda.gov
February 18, 2014	K132953	TIDISHEILD	PEM	Substantially Equivalent	Tidi Products,Llc	accessdata.fda.gov
August 14, 2013	K130421	MERON APPLICATION CAPSULES	EMA	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 24, 2013	K130125	MTA CEMENTS	KIF	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaeten	accessdata.fda.gov
December 27, 2012	K121549	NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE	LZA	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
February 1, 2012	K111515	SPSMEDICAL SPORVIEW STEAM BI	FRC	Substantially Equivalent	Spsmedical Supply Corp.	accessdata.fda.gov
December 21, 2011	K113563	N-HYBRIDE-COMPOSITE LC	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
December 8, 2010	K102984	AURA	EBF	Substantially Equivalent	Sdi Limited	accessdata.fda.gov
October 8, 2010	K101177	APEXNRG RIDER	LQY	Substantially Equivalent	Medicnrg , Ltd.	accessdata.fda.gov
July 9, 2010	K100907	NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL	LYY	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
July 23, 2009	K091894	TEMPORARY C&B COMPOSITE	EBG	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
March 5, 2009	K083755	NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS	LZA	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
February 23, 2009	K083101	PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES	EFB	Substantially Equivalent	Sable Industries, Inc.	accessdata.fda.gov
February 13, 2009	K083438	BIFIX SE	EMA	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
November 24, 2008	K082753	FUTURABOND M/FUTURABOND M SINGLE DOSE	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
October 16, 2008	K082258	CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR	FXX	Substantially Equivalent	Crosstex International	accessdata.fda.gov
November 14, 2007	K072554	ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES	EFB	Substantially Equivalent	Sable Industries, Inc.	accessdata.fda.gov
September 6, 2007	K071910	NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)	LZA	Substantially Equivalent	Hartalega Sdn Bhd	accessdata.fda.gov
August 17, 2007	K071190	ROOT ZX II	EKX	Substantially Equivalent	J. Morita USA, Inc.	accessdata.fda.gov
July 17, 2007	K070428	MEDICOM SELF-SEALING STERILIZATION POUCH	KCT	Substantially Equivalent	A.R. Medicom, Inc.	accessdata.fda.gov
June 7, 2007	K070723	FUTURABOND DC/SINGLE DOSE	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
May 24, 2007	K070595	SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR	FRC	Substantially Equivalent	Spsmedical Supply Corp.	accessdata.fda.gov
January 5, 2007	K063799	STEAMPLUS STEAM INTEGRATOR	JOJ	Substantially Equivalent	Spsmedical Supply Corp.	accessdata.fda.gov
October 19, 2006	K062418	K-SPRAY, MODEL 085-2715	EFB	Substantially Equivalent	Scican	accessdata.fda.gov
March 29, 2006	K053368	INTERPROXIMAL REDUCTION SYSTEM	EFB	Substantially Equivalent	Dentsply International	accessdata.fda.gov
September 20, 2005	K051291	NON-STERILE SURGICAL MASK	FXX	Substantially Equivalent	A.R. Medicom, Inc.	accessdata.fda.gov
December 1, 2004	K041913	POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE	LZA	Substantially Equivalent	Pt. Medisafe Technologies	accessdata.fda.gov
November 17, 2004	K042580	TIDI BRAND STERILIZATION WRAP	FRG	Substantially Equivalent	Banta Healthcare Group, Ltd.	accessdata.fda.gov
May 14, 2004	K041028	CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL	ELW	Substantially Equivalent	Crown Delta Corp.	accessdata.fda.gov
February 4, 2004	K040098	VARNISHAMERICA	LBH	Substantially Equivalent	Medical Products Laboratories, Inc.	accessdata.fda.gov
April 24, 2003	K030568	RADII	EBZ	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov
December 20, 2002	K024121	NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM	LYY	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
December 5, 2002	K023716	SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP	FRC	Substantially Equivalent	Spsmedical Supply Corp.	accessdata.fda.gov
June 6, 2002	K021220	NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS	LZA	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
November 1, 2001	K012767	S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL	ELW	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
July 27, 2001	K012060	MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT	ELC	Substantially Equivalent	Hu-Friedy Mfg. Co., Inc.	accessdata.fda.gov
January 11, 2000	K993526	SYNEA - LS LOW-SPEED HANDPIECE	EFB	Substantially Equivalent	A-Dec, Inc.	accessdata.fda.gov
September 10, 1999	K992011	SYNEA-HS HIGH SPEED-HANDPIECE	EFB	Substantially Equivalent	A-Dec, Inc.	accessdata.fda.gov
July 31, 1998	K981596	ULTRAPAK E	MVL	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
February 10, 1998	K974772	UFI GEL C	EBI	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
December 8, 1997	K973091	WAVE	EBF	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov
June 3, 1997	K971284	OPALDAM	EIG	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
May 6, 1997	K970794	LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)	LYY	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
February 12, 1997	K965162	LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.	GAM	Substantially Equivalent	Lukens Medical Corp.	accessdata.fda.gov
January 30, 1997	K962288	COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER	MMP	Substantially Equivalent	Pinnacle Products, Inc.	accessdata.fda.gov
December 6, 1996	K963922	ALPHA-DENT ROOT CANAL SEALER & FILLER	KIF	Substantially Equivalent	Wallace A. Erickson & Co.	accessdata.fda.gov
October 24, 1996	K963664	DENTAL HANDPIECE AND ACCESSORY	EFB	Substantially Equivalent	Filmtech, Inc.	accessdata.fda.gov
September 24, 1996	K962542	AIR MOTOR HANDPIECE TN-102	EFB	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
September 12, 1996	K962540	E-TYPE CONTRA ANGLE NAC-E	EGS	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
April 23, 1996	K961089	PULPDENT ENDOPREP II	EKL	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
October 3, 1995	K953504	MICROPRIME	KLE	Substantially Equivalent	Danville Engineering, Inc.	accessdata.fda.gov
August 25, 1995	K944711	W&H AIR MOTOR A25	EFB	Substantially Equivalent	A-Dec, Inc.	accessdata.fda.gov
January 11, 1995	K945142	POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)	ELW	Substantially Equivalent	Scican	accessdata.fda.gov
December 15, 1994	K925678	ATHENA HIGH SPEED HANDPIECE	EFB	Substantially Equivalent	Athena Technology, Inc.	accessdata.fda.gov
December 6, 1994	K931592	METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE	MED	Substantially Equivalent	Metrex Research Corp.	accessdata.fda.gov
December 6, 1994	K931052	METRICIDE 28	MED	Substantially Equivalent	Metrex Research Corp.	accessdata.fda.gov
November 10, 1994	K943949	POLYVIOLENE SURGICL SUTURE	GAT	Substantially Equivalent for Some Indications	Look, Inc.	accessdata.fda.gov
July 5, 1994	K941899	SDI COMPOSTIES	EBF	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov
March 10, 1994	K940410	NEW GEAR RELEASABLE HEADGEAR	DZB	Substantially Equivalent	Ortho Kinetics Corp.	accessdata.fda.gov
January 7, 1994	K930825	SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES	GAP	Substantially Equivalent	Surgical Specialties, Inc.	accessdata.fda.gov
January 7, 1994	K930248	VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM	ELW	Substantially Equivalent	Crown Delta Corp.	accessdata.fda.gov
September 20, 1993	K932794	PULPDENT SEAL-RITE LOW VISCOSITY	EBC	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
September 20, 1993	K932791	PULPDENT EDTA PREPARATIONS	KIF	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
July 30, 1992	K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	EJF	Substantially Equivalent	Cdb Corp.	accessdata.fda.gov
June 16, 1992	K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	JES	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
February 25, 1992	K915618	PROVICOL	EMA	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
November 7, 1991	K913573	SAFETY PLUS DENTAL INJECTION NEEDLE	DZM	Substantially Equivalent	Specialites Septodont	accessdata.fda.gov
June 10, 1991	K911287	PULPDENT SEAL RITE	EBC	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
October 25, 1990	K903029	STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE	GAR	Substantially Equivalent	Look, Inc.	accessdata.fda.gov
May 31, 1990	K896554	GUT SUTURES	GAL	Substantially Equivalent for Some Indications	Look, Inc.	accessdata.fda.gov
April 25, 1990	K901097	FILLOCK REAMER	DZA	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
July 15, 1988	K882576	ACID ETCH GEL	EBF	Substantially Equivalent	Pulpdent Corp. of America	accessdata.fda.gov
September 5, 1985	K852170	EZX YELLOW, BLUE OR ORANGE	EGZ	Substantially Equivalent	Strong Marketing	accessdata.fda.gov
June 7, 1982	K821221	DENTAL IMPRESSION MATERIAL	ELW	Substantially Equivalent	Crown Delta Corp.	accessdata.fda.gov
October 10, 1980	K802362	ALGINATE IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 27, 1980	K801639	PERMITE DENTAL AMALGAM ALLOY	EJJ	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 15, 2010	57242	Not yet classified	Terminated	SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Lig	Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product.	accessdata.fda.gov

Compare with other makers

Updated June 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.