Data / Medical devices / United States / Dentsply LLC

Dentsply LLC: FDA-registered device maker in Milford, DE, United States, 61 510(k) clearances

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

Dentsply LLC is registered with the FDA (registration 2515379) in Milford, DE, United States. It lists 36 device types. The FDA files 61 510(k) clearances under its listings, the newest dated April 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2515379
Address: 38 West Clarke Avenue, Milford, DE, United States, 19963
Owner or operator: DENTSPLY SIRONA INC (2511302)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 15, 1977
Registered through: 2026
Brand names listed: Adaptable Composite Resin, Aquasil Ulta+ Smart Wetting IMpression Material, Aquasil Ultra Cordless digit Power Dispenser, Aquasil Ultra Rigid, Aquasil Ultra XLV, Barricaid Perio Dressing, BioPure MTAD Root Canal Cleanser, Calibra Esthetic Resin Cement and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer, Specification developer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Contract manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Contract manufacturer	accessdata.fda.gov
Cleanser, Root Canal	KJJ	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Contract manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Specification developer	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Manufacturer, Specification developer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Contract manufacturer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Contract manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer, Specification developer	accessdata.fda.gov
Light Transmission Caries Detector	NTK	2	Specification developer	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Manufacturer, Specification developer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Contract manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer, Specification developer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Manufacturer	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
April 2, 2024	K240888	Calibra Abutment Resin Cement	EMA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
November 20, 2019	K191865	SmartLite Pro Modular LED Curing Light	EBZ	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 28, 2018	K181476	Prime&Bond active Universal Adhesive	KLE	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 27, 2016	K162107	TPH Spectra+ Universal Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
June 7, 2016	K160232	Disposable Barrier Sleeves and Covers	PEM	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
October 30, 2015	K151619	Prime&Bond Elect Universal Dental Adhesive	KLE	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
February 5, 2013	K123215	VISCOSTAT CLEAR	MVL	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
February 13, 2012	K113406	AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
December 28, 2011	K113040	CERAMIR CROWN & BRIDGE	EMA	Substantially Equivalent	Doxa Dental AB	accessdata.fda.gov
December 8, 2010	K102739	HYDROCOLOR 5	ELW	Substantially Equivalent	Cascades Device Consulting Associates	accessdata.fda.gov
September 28, 2010	K101710	LUXATEMP ULTRA /STAR	EBG	Substantially Equivalent	Dmg USA, Inc.	accessdata.fda.gov
April 14, 2009	K083841	ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
February 10, 2009	K083326	FLUOROCORE 2	EBF	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
January 23, 2008	K073173	SELF-ADHESIVE RESIN CEMENT	EMA	Substantially Equivalent	Dentsply Interntional	accessdata.fda.gov
December 19, 2007	K073117	DENTIN DESENSITIZER AGENT	LBH	Substantially Equivalent	Dentsply Intl., Inc.	accessdata.fda.gov
October 12, 2007	K072713	ION DENTAL RESIN SYSTEM	EBI	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
March 14, 2007	K070538	XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE	KLE	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 20, 2005	K052409	SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL	ELW	Substantially Equivalent	Sultan Chemists, Inc.	accessdata.fda.gov
July 12, 2005	K051463	XENO ADHESIVE WITH ACTIVATOR	KLE	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 22, 2005	K050880	DYRACT EXTRA RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 23, 2005	K050386	PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM	KLE	Substantially Equivalent	Dentsply International	accessdata.fda.gov
February 18, 2005	K043054	GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL	ELW	Substantially Equivalent	Sultan Chemists, Inc.	accessdata.fda.gov
June 16, 2004	K041343	XENO NM LIGHT CURED DENTAL ADHESIVE	KLE	Substantially Equivalent	Dentsply International	accessdata.fda.gov
June 16, 2004	K040906	CALIBRA CEMENT	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 1, 2004	K040144	QUIXX POSTERIOR RESTORATIVE	EBF	Substantially Equivalent	Dentsply International	accessdata.fda.gov
April 9, 2003	K030414	GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL	ELW	Substantially Equivalent	Sultan Chemists, Inc.	accessdata.fda.gov
May 13, 2002	K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
May 10, 2002	K021413	AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
May 8, 2002	K021410	AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
January 24, 2002	K013674	LUXATEMP/LUXATEMP SOLAR/INSTATEMP	EBG	Substantially Equivalent	Dmg USA, Inc.	accessdata.fda.gov
June 13, 2000	K001309	HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250	EBG	Substantially Equivalent	Kay See Dental Mfg. Co.	accessdata.fda.gov
January 13, 1999	K984387	R-30 AESTHETIC RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 15, 1998	K982318	SPECTRUM 800 CURING UNIT	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 18, 1998	K982395	DYTRACT FLOW RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
July 10, 1998	K981965	FLOWABLE COMPOSITE	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 9, 1998	K973221	COMPOSITE 168 RESTORATIVE SYSTEM	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 1, 1997	K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
June 30, 1997	K972234	RCT GEL ROOT CANAL THERAPY GEL	EIC	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
January 22, 1997	K964525	PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR	KLE	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
May 5, 1995	K951425	SPECTRUM CURING LIGHT POLYMERIZATION UNIT	EBZ	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 23, 1994	K943574	CAPTURE IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
June 10, 1994	K942031	CAULK TOOTH CONDITIONER GEL AND SYRINGE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
July 23, 1992	K922721	VLC DYCAL II	EJK	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 23, 1990	K896341	FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE	EBC	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 14, 1990	K896659	SILANE	KLE	Substantially Equivalent	Pulpdent Corp.	accessdata.fda.gov
March 17, 1989	K883842	DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 16, 1987	K873153	CAULK'S VPS CARTRIDGE SYSTEM	EID	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
July 2, 1987	K872251	ABRASIVE DISC - POLISHING WHEEL	EJR	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 7, 1987	K864720	LIGHT-CURED PERIODONTAL DRESSING	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
December 1, 1986	K863288	HYDROPHILIC REPROSIL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 17, 1986	K863552	IMPROVED COMSPAN	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 7, 1986	K863174	CAULK'S POLISHING PASTE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 19, 1986	K863522	MODIFIED SELF-CURE BONDING AGENT	KLE	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 19, 1986	K863092	DENTAL COMPOSITE RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
November 16, 1981	K812827	ORBIC* SPHERICAL ALLOY	EJJ	Substantially Equivalent	Johnson & Johnson Professionals, Inc.	accessdata.fda.gov
October 10, 1980	K802362	ALGINATE IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 7, 1980	K801142	PALODENT MATRICES & BITINE RINGS	DZN	Substantially Equivalent	Alvin Meyer, D.D.S.	accessdata.fda.gov
August 31, 1978	K781151	REPROSIL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
March 15, 1978	K780384	IMPROVED DYCAL	EJK	Substantially Equivalent	L.D. Caulk Co.	accessdata.fda.gov
February 28, 1978	K780301	CAULK TYLOK	EMA	Substantially Equivalent	L.D. Caulk Co.	accessdata.fda.gov

Compare with other makers

Updated April 2, 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.