Data / Medical devices / United States / Titanlinks Logistics LLC

Titanlinks Logistics LLC: FDA-registered device maker in Newark, DE, United States, 219 510(k) clearances

Name: Titanlinks Logistics LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Titanlinks Logistics LLC is registered with the FDA (registration 3044819802) in Newark, DE, United States. It lists 126 device types. The FDA files 219 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Titanlinks Logistics LLC

FDA registration number: 3044819802
Address: 73 Omega Dr Suite 280, Newark, DE, United States, 19713
Owner or operator: TitanLinks Logistics LLC (10095876)
Roles: Repackager or relabeler
First device listed: May 18, 2026
Registered through: 2027
Brand names listed: AH Plus, Adhesive, Adhesive, Bracket, Air polish, Amalgam, Applicator, Applicator, Absorbent Tipped, Non-Sterile, Articulating Paper Forceps and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	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
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Aligner, Bracket, Orthodontic	ECQ	1	Repackager or relabeler	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	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
Bur, Dental	EJL	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
Carrier, Amalgam, Operative	EKI	1	Repackager or relabeler	accessdata.fda.gov
Carver, Dental Amalgam, Operative	EKH	1	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Rubber Dam	EEF	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Repackager or relabeler	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Repackager or relabeler	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	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, Mattress (Medical Purposes)	FMW	1	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	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	HTF	1	Repackager or relabeler	accessdata.fda.gov
Curette, Endodontic	EKT	1	Repackager or relabeler	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Repackager or relabeler	accessdata.fda.gov
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief	MZW	2	Repackager or relabeler	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	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
Drape, Surgical, Exempt	PUI	2	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
Eraser, Dental Stain	MAU	1	Repackager or relabeler	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Repackager or relabeler	accessdata.fda.gov
Explorer, Operative	EKB	1	Repackager or relabeler	accessdata.fda.gov
External Cleaning Solution	PME	2	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
File, Periodontic	EMR	1	Repackager or relabeler	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	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	HTD	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	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
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Repackager or relabeler	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	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
Instrument, Hand, Calculus Removal	ELA	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Knife, Surgical	EMF	1	Repackager or relabeler	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Repackager or relabeler	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	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
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	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
Patient Personal Hygiene Kit	NSB	1	Repackager or relabeler	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Pliers, Surgical	HTC	1	Repackager or relabeler	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Repackager or relabeler	accessdata.fda.gov
Point, Abrasive	EHL	1	Repackager or relabeler	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Post, Root Canal	ELR	1	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	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
Saliva, Artificial	LFD	U	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
Scissors, Orthopedic, Surgical	HRR	1	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Repackager or relabeler	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	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, 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
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Ent	KCP	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, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Teeth, Porcelain	ELL	2	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Tube Impression And Matrix	KCQ	1	Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	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
Wrap, Sterilization	FRG	2	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. Newest 100 of 219.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 27, 2025	K251716	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate	LZA	Substantially Equivalent	Basic Medical Technology, Inc.	accessdata.fda.gov
June 10, 2025	K250735	Dental Barrier and Sleeves	PEM	Substantially Equivalent	Fomed Industries, Inc.	accessdata.fda.gov
February 18, 2025	K243792	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)	LZA	Substantially Equivalent	Basic Medical Technology, Inc.	accessdata.fda.gov
January 31, 2025	K243441	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)	LZA	Substantially Equivalent	Basic Medical Technology, Inc.	accessdata.fda.gov
July 3, 2023	K230487	Dental Lithium Disilicate Glass-Ceramic	EIH	Substantially Equivalent	Fuzhou Rick Brown Biomaterials Co., Ltd.	accessdata.fda.gov
February 13, 2023	K221875	Sterilization Pouch and Roll	FRG	Substantially Equivalent	Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.	accessdata.fda.gov
July 19, 2022	K220777	Surgical face mask	FXX	Substantially Equivalent	Hubei Qianjiang Kingphar Medical Material Co., Ltd.	accessdata.fda.gov
April 25, 2022	K220512	Disposable Surgical Face Mask (M01, M02)	FXX	Substantially Equivalent	Fomed Industries, Inc.	accessdata.fda.gov
December 9, 2021	K213149	VOCO Retraction Paste	MVL	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
December 31, 2019	K192444	mCare® Powder Free Nitrile Black Examination Glove	LZA	Substantially Equivalent	Mercator Medical (Thailand), Ltd.	accessdata.fda.gov
December 9, 2019	K181900	Dental high speed handpiece, Dental low speed handpiece	EFB	Substantially Equivalent	Foshan Cicada Dental Instrument Co, Ltd.	accessdata.fda.gov
November 22, 2019	K192260	everX Flow	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 8, 2019	K191448	Barrier Sleeves	PEM	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
October 8, 2019	K191133	KATANA Cleaner, KATANA Cleaner (Trial)	PME	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
July 29, 2019	K190339	Helioseal F Plus	EBC	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
March 14, 2019	K183380	Tetric PowerFill	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
December 18, 2018	K181496	VINTAGE PRO	EIH	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
April 13, 2018	K172930	mCare Powder-free Blue Nitrile Examination Gloves	LZA	Substantially Equivalent	Mercator Medical (Thailand), Ltd.	accessdata.fda.gov
March 8, 2018	K173500	NMF004A	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 27, 2018	K173275	OMNICHROMA	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
April 28, 2017	K162258	Self Sealing Sterilization Pouches	FRG	Substantially Equivalent	Tianchang Jiarui Packaging Material Co., Ltd.	accessdata.fda.gov
April 4, 2017	K163613	Bluephase Style 20i	EBZ	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
September 27, 2016	K162107	TPH Spectra+ Universal Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 29, 2016	K153493	Clip Flow	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 27, 2016	K160596	BEAUTIFIL II LS	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
July 27, 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
July 6, 2016	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 30, 2016	K153177	Admira Fusion Flow	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 14, 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 12, 2016	K153753	TelioCAD Multi	EBG	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
March 3, 2016	K153253	GC Reline II	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 2, 2016	K151700	BEAUTIFIL II Gingiva	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
December 10, 2015	K151699	BEAUTIFIL II Enamel	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
September 9, 2015	K143637	U&U Sterilization Pouch and Roll	FRG	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
July 31, 2015	K151053	PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner	MUH	Substantially Equivalent	Sopro - Acteon Group	accessdata.fda.gov
July 7, 2015	K150933	iBond Universal & iBond Ceramic Primer	KLE	Substantially Equivalent	Heraeus Kulzer, LLC, Mitsui Chemicals Group	accessdata.fda.gov
April 20, 2015	K143140	G-Premio BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 25, 2014	K142389	Variolink Esthetic	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
September 5, 2014	K141562	MSN-006	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 14, 2014	K133824	CERASMART	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 6, 2014	K133836	OPTIGLAZE COLOR	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 11, 2014	K133318	ADHESE UNIVERSAL	KLE	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
November 1, 2013	K132450	CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND	KLE	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
October 3, 2013	K132141	BEAUTIFIL BULK FLOWABLE	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
September 6, 2013	K131442	FIRECR DENTALIMAGING SYSTEM	MUH	Substantially Equivalent	3Disc Americas	accessdata.fda.gov
July 11, 2013	K131248	ETCH GEL	KLE	Substantially Equivalent	Dmg America, LLC	accessdata.fda.gov
December 7, 2012	K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	KLE	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
August 29, 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
May 23, 2012	K112800	SUNTOUCH TOPICAL HEMOSTATIC DRESSING	QSY	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
May 10, 2012	K120521	GC BLUE SILICONE	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 19, 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
December 14, 2011	K112501	VENUS PEARL PLT REFILL A1	EBF	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
November 17, 2011	K111982	CLEARFIL DC CORE PLUS	EBF	Substantially Equivalent	Kuraray America, Inc.	accessdata.fda.gov
October 14, 2011	K111958	TETRIC EVOCERAM BULK FILL	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
June 17, 2011	K110871	FIT CHECKER ADVANCED	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 19, 2011	K110302	ADHESIVE EXL-759	KLE	Substantially Equivalent	3M Espe AG	accessdata.fda.gov
May 5, 2011	K111185	RELYX LUTING PLUS AUTOMIX	EMA	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
February 25, 2011	K103528	IPS EMPRESS DIRECT FLOW	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
February 14, 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY	EBG	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
January 27, 2011	K101346	GC ORAL MOISTURIZING GEL	LFD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
December 22, 2010	K102808	MI VARNISH	LBH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 21, 2010	K100172	TOKUYAMA SHIELD FORCE	LBH	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
September 28, 2010	K101710	LUXATEMP ULTRA /STAR	EBG	Substantially Equivalent	Dmg USA, Inc.	accessdata.fda.gov
September 17, 2010	K101420	GC FUJI TEMP	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
August 23, 2010	K101603	BEAUTIFIL FLOW PLUS	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
August 19, 2010	K101493	ADVANCED GLASS IONOMER (K-130) RESTORATIVE	EMA	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
May 12, 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
March 10, 2010	K093744	EXCITE F AND EXCITE DSC	KLE	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
March 10, 2010	K092141	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	LBH	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
March 5, 2010	K100328	CLEARFIL MAJETY POSTERIOR	EBF	Substantially Equivalent	Kuraray Medical, Inc.	accessdata.fda.gov
February 19, 2010	K093721	COSP2	MVL	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
July 31, 2009	K091494	FLEXITIME FLOW	ELW	Substantially Equivalent	Heraeus Kulzer, Inc.	accessdata.fda.gov
July 22, 2009	K091388	GCUC-505	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 17, 2009	K091106	EQUIA	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 4, 2009	K091019	SPEEDCEM	EMA	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
May 21, 2009	K091023	METAMORPHOSIS	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
May 11, 2009	K090826	MONOBOND PLUS	KLE	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
April 29, 2009	K090701	EMPRESS DIRECT	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
April 28, 2009	K083695	TRAXODENT	MVL	Substantially Equivalent	Premier Dental Products Co.	accessdata.fda.gov
January 21, 2009	K083652	IBOND TOTAL ETCH	KLE	Substantially Equivalent	Heraeus Kulzer,GmbH	accessdata.fda.gov
December 17, 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
December 11, 2008	K082744	BEAUTIBOND	KLE	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
October 21, 2008	K082768	G-BOND PLUS	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 19, 2008	K080940	ESTELITE SIGMA QUICK	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
June 9, 2008	K080684	WG-SURGICAL SUTURES WITH NEEDLE	GAP	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
April 30, 2008	K073614	WG-SURGICAL SUTURES WITH NEEDLE	NEW	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
February 15, 2008	K073697	TRANSBOND SUPREME ADHESIVE	DYH	Substantially Equivalent	3M Unitek	accessdata.fda.gov
February 4, 2008	K073554	NEUN	EBF	Substantially Equivalent	Heraeus Kulzer,GmbH	accessdata.fda.gov
January 29, 2008	K073209	MAXCEM 2	MZW	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
December 27, 2007	K071886	SELF SEAL STERILIZATION POUCH	FRG	Substantially Equivalent	Shanghai Jianzhong Medical Packaging Co., Ltd.	accessdata.fda.gov
August 15, 2007	K071742	BEAUTIFIL II	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
July 19, 2007	K071288	MODIFICATION TO KAVO QUATTROCARE	EBF	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
June 7, 2007	K070723	FUTURABOND DC/SINGLE DOSE	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 12, 2007	K070854	GC MI PASTE PLUS	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070698	COE COMFORT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070697	COE SOFT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 21, 2007	K070325	CLEARFIL MAJESTY ESTHETIC PLT	EBF	Substantially Equivalent	Kuraray Medical, Inc.	accessdata.fda.gov
July 14, 2006	K061535	GC XLC-100 CAPSULE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 24, 2006	K060684	ADPER PROMPT, ADPER PROMPT L-POP	KLE	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov

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Updated August 27, 2025. 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.