Not currently registered with FDA under this name

Dentsply Intl., Inc.

York, PA, United States. Named as applicant on 266 dental 510(k) clearances between 1976 and 2014. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 2661976–2014
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 1976–2026

510(k) clearances

Clearances on which FDA names Dentsply Intl., Inc. as the applicant.

Decided	510(k)	Device	Device type
20 Aug 2014	K140347	ANKYLOS C/X IMPLANT SYSTEM	DZE Root-Form Endosseous Implant
23 Jul 2013	K130862	CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM	ELC Ultrasonic Scaler
22 Feb 2013	K123615	IRIS - HIGH STRENGTH GLASS CERAMIC	EIH Porcelain Powder
30 Oct 2009	K093221	PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II	DYH Resin Bracket and Tooth Conditioner Adhesive
22 May 2009	K083805	ANKYLOS C/X DENTAL IMPLANT SYSTEM	DZE Root-Form Endosseous Implant
29 Oct 2008	K082198	DURASHIELD PLUS	LBH Cavity Varnish
27 Mar 2008	K072730	FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS	NHA Endosseous Dental Implant Abutment
28 Jan 2008	K072989	AXIS SYSTEM	EFB Dental Air-Powered Handpiece
19 Dec 2007	K073117	DENTIN DESENSITIZER AGENT	LBH Cavity Varnish
14 Mar 2007	K070538	XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE	KLE Resin Tooth Bonding Agent
26 Jan 2007	K070019	CARRARA VOLUMIA	EIH Porcelain Powder
26 Jun 2006	K061427	PRE-IMPRESSION CONDITIONING SOLUTION	ELW Impression Material
2 Sep 2005	K052334	CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131	ELC Ultrasonic Scaler
15 Jul 2005	K051707	ECLIPSE BONDING AGENT	KLE Resin Tooth Bonding Agent
12 Jul 2005	K051463	XENO ADHESIVE WITH ACTIVATOR	KLE Resin Tooth Bonding Agent
24 Jun 2005	K051462	MODIFICATION TO: CERCON BASE	EIH Porcelain Powder
22 Apr 2005	K050880	DYRACT EXTRA RESTORATIVE	EBF Resin Tooth Shade Material
6 Apr 2005	K050750	LC BRACKET ADHESIVE SYSTEM	DYH Resin Bracket and Tooth Conditioner Adhesive
22 Dec 2004	K043247	DUCERA ALLCERAM	EIH Porcelain Powder
4 Nov 2004	K042905	NEO-CLIP ORTHODONTIC BRACKET ACCESSORY	NJM Orthodontic Ceramic Bracket
18 Oct 2004	K041272	DYRACT CEM PLUS CEMENT	EMA Dental Cement
30 Aug 2004	K042178	ORTHODONTIC CERAMIC BRACKETS	NJM Orthodontic Ceramic Bracket
30 Jul 2004	K041707	CERCON CERAM EXPRESS CERAMIC SYSTEM	EIH Porcelain Powder
16 Jun 2004	K041141	DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125	EFB Dental Air-Powered Handpiece
16 Jun 2004	K040906	CALIBRA CEMENT	EMA Dental Cement
21 May 2004	K040895	INTEGRITY TEMPORARY CEMENT	EMA Dental Cement
2 Apr 2004	K040375	IDEAL 1 ORTHODONTIC BAND CEMENT	DYH Resin Bracket and Tooth Conditioner Adhesive
30 Mar 2004	K040635	CARRARA INTERACTION CERAMIC SYSTEM	EIH Porcelain Powder
18 Mar 2004	K040421	DUCERAGOLD PORCELAINS	EIH Porcelain Powder
18 Mar 2004	K040420	DUCERAM PLUS CERAMIC SYSTEM	EIH Porcelain Powder
6 Feb 2004	K033703	IDEAL 1 ORTHODONTIC BRACKET ADHESIVE	DYH Resin Bracket and Tooth Conditioner Adhesive
23 Jan 2004	K033667	CARRARA PRESS SYSTEM	EIH Porcelain Powder
2 Dec 2003	K033553	PFZ PORCELAIN SYSTEM	EIH Porcelain Powder
14 Oct 2003	K032904	ACUCAM CONCEPT IV FWT, MODEL 110-0185G1	EIA Operative Dental Unit
30 Sep 2003	K032317	ORION GX ALLOY	EJT Gold-Based Noble Metal Alloy
30 Sep 2003	K032316	ORION E ALLOY	EJT Gold-Based Noble Metal Alloy
26 Sep 2003	K032892	MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM	EBI Rebasing Repairing Relining Denture Resin
15 Sep 2003	K031932	FLUORIDE VARNISH	LBH Cavity Varnish
5 Aug 2003	K031461	CARRIER TIPS	ELC Ultrasonic Scaler
15 Jul 2003	K031145	ESTYLUS ELECTRIC MOTOR SYSTEM	EFB Dental Air-Powered Handpiece
23 Jan 2003	K023776	XENO III DENTAL ADHESIVE	KLE Resin Tooth Bonding Agent
6 Sep 2002	K022796	CERCON CERAM S PORCELAIN	EIH Porcelain Powder
19 Aug 2002	K021805	SEAL & PROTECT PROTECTIVE SEALANT	LBH Cavity Varnish
13 May 2002	K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
10 May 2002	K021413	AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
8 May 2002	K021410	AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
15 Mar 2002	K014188	NEW PROPHY POWDER	KOJ Airbrush
8 Nov 2001	K012720	TULSA CONTRA ANGLES	EFB Dental Air-Powered Handpiece
12 Jul 2001	K011560	TRUBYTE DENTURE BASE RESIN SYSTEM	EBI Rebasing Repairing Relining Denture Resin
24 Jan 2001	K003921	DYRACT CEM LCI COMPOMER	EMA Dental Cement
9 Jan 2001	K003518	RAPIDD HIGHSPEED DENTAL HANDPIECE	EFB Dental Air-Powered Handpiece
28 Sep 2000	K002387	COMFORT CONTROL SYRINGE SYSTEM	EJI Cartridge Syringe
16 Jun 2000	K000996	TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND	EFT Over the Counter Denture Cleanser
13 Apr 2000	K000112	ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401	EIA Operative Dental Unit
24 Mar 2000	K000169	NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN	EJR Oral Cavity Abrasive Polishing Agent
14 Mar 2000	K994285	ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH	EHD Extraoral with Timer X-Ray Unit
17 Nov 1999	K992822	SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE	LBH Cavity Varnish
22 Oct 1999	K992519	NRC NON-RINSE CONDITIONER	EBC Pit and Fissure Sealant and Conditioner
6 Oct 1999	K992956	LUCITONE FRS FLEXIBEL DENTAL RESIN	EBI Rebasing Repairing Relining Denture Resin
22 Sep 1999	K992518	PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM	EBC Pit and Fissure Sealant and Conditioner
7 Sep 1999	K992610	GENDEX 765DC, MODEL 110-0154	EHD Extraoral with Timer X-Ray Unit
27 Aug 1999	K992516	DYRACT SEAL COMPOMER PIT & FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
20 Aug 1999	K991909	DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
29 Jan 1999	K983966	NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN	EJR Oral Cavity Abrasive Polishing Agent
13 Jan 1999	K984387	R-30 AESTHETIC RESTORATIVE	EBF Resin Tooth Shade Material
6 Oct 1998	K982564	DELTON FS DIRECT DELIVERY SYSTEM	EBC Pit and Fissure Sealant and Conditioner
21 Sep 1998	K982394	PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM	KLE Resin Tooth Bonding Agent
15 Sep 1998	K982318	SPECTRUM 800 CURING UNIT	EBF Resin Tooth Shade Material
18 Aug 1998	K982395	DYTRACT FLOW RESTORATIVE	EBF Resin Tooth Shade Material
31 Jul 1998	K981620	MTA MATERIAL II	KIF Root Canal Filling Resin
22 Jul 1998	K982007	TRUBYTE DENTURE BOND DENTURE BONDING AGENT	KLE Resin Tooth Bonding Agent
10 Jul 1998	K981965	FLOWABLE COMPOSITE	EMA Dental Cement
14 Apr 1998	K980543	DENOPTIX BARRIER ENVELOPE (SIZE 0-4)	EHD Extraoral with Timer X-Ray Unit
24 Feb 1998	K980332	MTA MATERIAL	KIF Root Canal Filling Resin
9 Feb 1998	K973221	COMPOSITE 168 RESTORATIVE SYSTEM	EBF Resin Tooth Shade Material
5 Feb 1998	K973235	DYRACT AP RESTORATIVE	EBF Resin Tooth Shade Material
5 Jan 1998	K974140	ADHESIVE HYBRID IONOMER CEMENT	EMA Dental Cement
17 Dec 1997	K974035	CENTURY ALLOY	EJJ Amalgam Alloy
11 Dec 1997	K973781	AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL	ELW Impression Material
4 Dec 1997	K973782	AQUASIL XLV SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
16 Sep 1997	K972573	LIQCRYLIC PRO DENTAL RESIN	EBI Rebasing Repairing Relining Denture Resin
11 Sep 1997	K971869	FINESSE ALL-CERAMIC SYSTEM	EIH Porcelain Powder
30 Jun 1997	K972234	RCT GEL ROOT CANAL THERAPY GEL	EIC Irrigating Endodontic Periodontic Syringe
4 Jun 1997	K971603	STERILE SUREFLEX FILES AND INSTRUMENTS	EFA Dental Belt and/or Gear Driven Handpiece
3 Jun 1997	K971606	STERILE FLEXOFILE FILES AND INSTRUMENTS	EFA Dental Belt and/or Gear Driven Handpiece
11 Apr 1997	K970123	DENTSPLY CAVITRON SPS SCALER SYSTEM	ELC Ultrasonic Scaler
4 Apr 1997	K970342	CAVITRON JET WITH SPS SYSTEM	ELC Ultrasonic Scaler
27 Mar 1997	K970433	AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
4 Mar 1997	K964046	DENTSPLY PRECISION TORQUE SYSTEM	DZE Root-Form Endosseous Implant
22 Jan 1997	K964525	PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR	KLE Resin Tooth Bonding Agent
23 Dec 1996	K964659	ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM	EHD Extraoral with Timer X-Ray Unit
6 Dec 1996	K964040	TRUBYTE SOFT RELINE SYSTEM	EBI Rebasing Repairing Relining Denture Resin
13 Aug 1996	K952614	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	ELW Impression Material
18 Jul 1996	K962348	PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT	KLE Resin Tooth Bonding Agent
28 May 1996	K961291	FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS	EIH Porcelain Powder
26 Apr 1996	K960823	PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT	KLE Resin Tooth Bonding Agent
26 Apr 1996	K960548	AH PLUS ROOT CANAL SEALER	KIF Root Canal Filling Resin
1 Mar 1996	K960028	ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM	EAP Intraoral X-Ray Unit
2 Nov 1995	K954761	FINESSE LOW-FUSING PORCELAIN SYSTEM	EIH Porcelain Powder
7 Jul 1995	K952351	PRECISE DENTURE BASE RESIN	EBI Rebasing Repairing Relining Denture Resin
22 Jun 1995	K951607	SUREFLEX FILES	EKJ Operative Burnisher
23 May 1995	K951864	PRIME & BOND DIRECT COMPOSITE BONDING AGENT	KLE Resin Tooth Bonding Agent
5 May 1995	K951425	SPECTRUM CURING LIGHT POLYMERIZATION UNIT	EBZ Ultraviolet Activator for Polymerization
3 May 1995	K951296	DELTON F PIT & FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
23 Mar 1995	K950991	DYRACT II RESTORATIVE	EBF Resin Tooth Shade Material
29 Dec 1994	K945769	TOTAL ETCH GEL	EBF Resin Tooth Shade Material
21 Sep 1994	K943584	PRESTERILIZED ENDODONTIC FILES	EKJ Operative Burnisher
29 Aug 1994	K943582	SOFTWEAR PORCELAIN SYSTEM	EIH Porcelain Powder
29 Aug 1994	K940914	NEW LUTING CEMENT MATERIAL (NLC)	EMA Dental Cement
23 Aug 1994	K943574	CAPTURE IMPRESSION MATERIAL	ELW Impression Material
10 Jun 1994	K942031	CAULK TOOTH CONDITIONER GEL AND SYRINGE	EBF Resin Tooth Shade Material
10 Jun 1994	K941572	FLUORIDE-PSA PRIME/ADHESIVE	KLE Resin Tooth Bonding Agent
23 May 1994	K941392	JET UNIT (CJ HANDPIECE)	ELC Ultrasonic Scaler
29 Apr 1994	K940459	MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)	EMA Dental Cement
28 Apr 1994	K940685	PRETREATMENT SOLUTION	ELW Impression Material
1 Mar 1994	K940252	FINESSE PORCELAIN SYSTEM	EIH Porcelain Powder
25 Aug 1993	K932395	VLC DR MATERIAL	EBF Resin Tooth Shade Material
22 Jul 1993	K930698	THE MODEL 3003 SCALER	ELC Ultrasonic Scaler
8 Jul 1993	K931812	NEW DENTINE ADHESIVE	KLE Resin Tooth Bonding Agent
8 Jul 1993	K931229	VARIGLASS VLC GLASS IONOMER	EMA Dental Cement
27 May 1993	K930504	NEW DENTIN PRIMER	KLE Resin Tooth Bonding Agent
12 Apr 1993	K923473	MULTIPURPOSE RESIN CEMENT	EMA Dental Cement
31 Mar 1993	K926406	DUAL CURE RELINE MATERIAL	EBI Rebasing Repairing Relining Denture Resin
23 Dec 1992	K920684	NEW TOOTH MATERIAL	ELM Teeth Plastic Denture
17 Nov 1992	K923979	LC TRAY MATERIAL	EBH Resin Impression Tray Material
26 Oct 1992	K923639	DIAMOND COATED DENTAL INSERTS	ELC Ultrasonic Scaler
29 Sep 1992	K923586	BURNOUT MATERIAL	EGD Intraoral Dental Wax
11 Sep 1992	K923236	TRIAD INLAY COMPOSITE	EBF Resin Tooth Shade Material
9 Sep 1992	K923328	VENEER CEMENT	EMA Dental Cement
23 Jul 1992	K922721	VLC DYCAL II	EJK Calcium Hydroxide Cavity Liner
2 Jul 1992	K921619	DENTAL PORCELAIN	EIH Porcelain Powder
16 Jun 1992	K922380	BITE RIM WAX	EGD Intraoral Dental Wax
28 Apr 1992	K920758	JENKER NEEDLE STICK PROTECTOR	DZM Dental Needle
19 Mar 1992	K915543	NEW OPAQUE PORCELAIN	EIH Porcelain Powder
2 Mar 1992	K915830	PRISMA UNIVERSAL BOND(R) 3	KLE Resin Tooth Bonding Agent
9 Dec 1991	K914186	ULTRACROWN(TM) PRE-SOLDER	EJT Gold-Based Noble Metal Alloy
13 Nov 1991	K913860	ULTRACROWN(TM) PD ALLOY POST-SOLDER	EJS Alloy Other Noble Metal
17 Oct 1991	K913836	VLC GLASS IONOMER	EMA Dental Cement
16 Sep 1991	K912945	SATIN PROPHYLAXIS PASTE	EJR Oral Cavity Abrasive Polishing Agent
6 Sep 1991	K913232	ULTRACROWN(TM) PD DENTAL ALLOY	EJS Alloy Other Noble Metal
28 Jun 1991	K911244	VLC GLASS IONOMER LINER	EJK Calcium Hydroxide Cavity Liner
29 Apr 1991	K905702	NEW TRIAD TRANSHEET DENTURE BASE MATERIAL	EBI Rebasing Repairing Relining Denture Resin
20 Feb 1991	K905476	STOMADENT TM	EBF Resin Tooth Shade Material
10 Oct 1990	K903163	PERIODONTAL DEBRIDING SOLUTION E	ELC Ultrasonic Scaler
19 Sep 1990	K901524	CHEMFIL II CAPS	EMA Dental Cement
6 Sep 1990	K901580	PROPHY PASTE	EJR Oral Cavity Abrasive Polishing Agent
13 Aug 1990	K902413	SONIC SCALER	ELC Ultrasonic Scaler
15 May 1990	K896340	BIOMER(R) F COMPOSITE LUTING CEMENT	EMA Dental Cement
23 Apr 1990	K896341	FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE	EBC Pit and Fissure Sealant and Conditioner
16 Apr 1990	K900393	OPAQUE PORCELAIN	EIH Porcelain Powder
10 Apr 1990	K900507	DISPOSABLE SCREW TYPE PROPHY BRUSH	EHK Prophylaxis Cup
6 Apr 1990	K900093	DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER	EFB Dental Air-Powered Handpiece
2 Apr 1990	K895487	TEMPORARY DENTAL CEMENT	EMA Dental Cement
14 Mar 1990	K897101	DISPOSABLE PROPHY ANGLE AND ACCESSORIES	EFB Dental Air-Powered Handpiece
9 Feb 1990	K896564	DENTAL CORE MATERIAL	EBF Resin Tooth Shade Material
18 Dec 1989	K895742	LITELINE VLC SOFT RELINE	EBI Rebasing Repairing Relining Denture Resin
6 Oct 1989	K894247	PERIODONTAL IRRIGATING SOLUTION-D	ELC Ultrasonic Scaler
18 May 1989	K891455	DENTIN PRIMER	KLE Resin Tooth Bonding Agent
17 Apr 1989	K884166	DICOR CERAMIC INLAY - NEW TECHNIC	ELW Impression Material
17 Mar 1989	K883842	DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.	ELW Impression Material
29 Nov 1988	K882751	GLASS IONOMER BASE	EJK Calcium Hydroxide Cavity Liner
6 Sep 1988	K882145	PHOTO-CURING LIGHT	EBZ Ultraviolet Activator for Polymerization
12 Aug 1988	K882482	TRIAD ORTHODONTIC GEL	EBI Rebasing Repairing Relining Denture Resin
18 May 1988	K880774	SPECTRUM	ELL Porcelain Teeth
2 May 1988	K880542	DENTALVISION TV SYSTEM	EKJ Operative Burnisher
27 Apr 1988	K880209	PERIODONTAL PROBE - AUTOPROBE	EIL Dental Instrument Depth Gauge
23 Feb 1988	K875150	PERIODONTAL SCALING SOLUTION-C	EFS Oral Irrigation Unit
23 Feb 1988	K875149	PERIDONTAL SCALING SOLUTION-B	EFS Oral Irrigation Unit
23 Feb 1988	K875132	PERIODONTAL SCALING SOLUTION-A	EFS Oral Irrigation Unit
19 Feb 1988	K874945	CEMENT LINER	EMA Dental Cement
8 Feb 1988	K874944	MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
29 Dec 1987	K874074	TEMPORARY DISCLOSING SOLUTION	KLE Resin Tooth Bonding Agent
16 Sep 1987	K873153	CAULK'S VPS CARTRIDGE SYSTEM	EID Restorative and Impression Material Syringe
25 Aug 1987	K873209	PLAQUE-SWEEP	EFB Dental Air-Powered Handpiece
11 Aug 1987	K872943	DISPOSABLE ARTICULATOR	EJP Articulators
3 Aug 1987	K872907	DENTIN ADHESIVE	EBF Resin Tooth Shade Material
2 Jul 1987	K872251	ABRASIVE DISC - POLISHING WHEEL	EJR Oral Cavity Abrasive Polishing Agent
22 Jun 1987	K872210	IMPRESSION TRAY	EBH Resin Impression Tray Material
5 Jun 1987	K871937	IMPRESSION SYRINGE	EID Restorative and Impression Material Syringe
27 May 1987	K871909	COMPOSITE RESTORATIVE CARRIER	EIY Dental Plastic Filling Instrument
7 Apr 1987	K864720	LIGHT-CURED PERIODONTAL DRESSING	EMA Dental Cement
19 Feb 1987	K864996	ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30	ELC Ultrasonic Scaler
17 Feb 1987	K864724	MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN	ELL Porcelain Teeth
21 Jan 1987	K864725	MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES	EMA Dental Cement
1 Dec 1986	K863288	HYDROPHILIC REPROSIL	ELW Impression Material
17 Oct 1986	K863552	IMPROVED COMSPAN	EBF Resin Tooth Shade Material
7 Oct 1986	K863174	CAULK'S POLISHING PASTE	EBF Resin Tooth Shade Material
25 Sep 1986	K862879	NEW LIGHT-CURING IMPRESSION MATERIAL	ELW Impression Material
19 Sep 1986	K863522	MODIFIED SELF-CURE BONDING AGENT	KLE Resin Tooth Bonding Agent
19 Sep 1986	K863092	DENTAL COMPOSITE RESTORATIVE	EBF Resin Tooth Shade Material
5 Sep 1986	K863324	TRIAD IMPACT	EBI Rebasing Repairing Relining Denture Resin
31 Jul 1986	K862660	PRISMA METAL OPAQUERS	EBC Pit and Fissure Sealant and Conditioner
26 Mar 1986	K860608	ARTIFICIAL TEETH, PORCELAIN, MODIFIED	ELL Porcelain Teeth
26 Mar 1986	K860569	ENDODONTIC ROOT CANAL PLUGGER	EKR Endodontic Root Canal Plugger
17 Mar 1986	K860437	PARTIAL DENTURE ALLOY	EJH Base Metal Alloy
17 Mar 1986	K860146	POLYJEL N.F. (NEW FORMULA)	ELW Impression Material
16 Dec 1985	K854253	ROOT CANAL FILLING RESIN	KIF Root Canal Filling Resin
19 Nov 1985	K853707	DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES	EIH Porcelain Powder
7 Nov 1985	K854042	RESIN TRAY IMPRESSION MATERIAL	EBH Resin Impression Tray Material
7 Nov 1985	K853523	VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE	DYH Resin Bracket and Tooth Conditioner Adhesive
31 Oct 1985	K853431	DENTAL CEMENT	EBF Resin Tooth Shade Material
16 Aug 1985	K853052	INTEGRITY	EBG Resin Temporary Crown and Bridge
30 Jul 1985	K852659	BIOGLOSS	EBF Resin Tooth Shade Material
25 Jul 1985	K852660	ETCH AND BOND	KLE Resin Tooth Bonding Agent
24 Jul 1985	K852658	ETEN-GEL	EBF Resin Tooth Shade Material
1 Jul 1985	K852151	PHOTO CURING LIGHT	EBF Resin Tooth Shade Material
22 Apr 1985	K851056	OPAQUER/BONDING AGENT	KLE Resin Tooth Bonding Agent
16 Apr 1985	K850911	TRIAD C & B MATERIAL	EBF Resin Tooth Shade Material
18 Mar 1985	K850641	CAULK DYCAL LIGHT CURED	EBD Resin Filling Material Coating
8 Feb 1985	K844471	VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE	EBH Resin Impression Tray Material
9 Jan 1985	K844308	PIT AND FISSURE SEAANTS	EBC Pit and Fissure Sealant and Conditioner
2 Aug 1984	K842551	BASE METAL ALLOY	EJH Base Metal Alloy
11 May 1984	K840751	OPAQUE COATING & SURFACE STAIN	EBD Resin Filling Material Coating
2 Mar 1984	K832919	OPTI-BEAM IV	EAZ Dental Operating Light
27 Feb 1984	K834409	DENTURE BASE RESIN	EBI Rebasing Repairing Relining Denture Resin
3 Jan 1984	K833955	NOVEL DISPENSER/PACKAGE	EIY Dental Plastic Filling Instrument
27 Dec 1983	K833512	PARTIAL DENTURE ALLOY	EJH Base Metal Alloy
1 Sep 1983	K832292	SOLO-TACH	DYH Resin Bracket and Tooth Conditioner Adhesive
31 Aug 1983	K832320	PRISMA III	EBZ Ultraviolet Activator for Polymerization
31 Aug 1983	K832291	AUTO-TACH	DYH Resin Bracket and Tooth Conditioner Adhesive
30 Jun 1983	K831647	DENTURE RELINING, REPAIR/REBASING RESIN	EBI Rebasing Repairing Relining Denture Resin
9 May 1983	K831214	DELTA TEETH	ELM Teeth Plastic Denture
9 May 1983	K830955	DENTAL CERAMIC FOR FABRICATION OF CROWN	EIH Porcelain Powder
6 Apr 1983	K830553	DENTAL PORCELAIN POWDER	EIH Porcelain Powder
17 Mar 1983	K830442	PRISMA-FINE	EBF Resin Tooth Shade Material
26 Jan 1983	K823928	TOOTH CONDITIONER	DYH Resin Bracket and Tooth Conditioner Adhesive
28 Dec 1982	K823744	PORCELAIN ARTIFICIAL TEETH	ELL Porcelain Teeth
16 Aug 1982	K822094	DENTAL MATRIX BAND	DZN Dental Hand Instruments
23 Mar 1982	K820215	IMPROVED DYCAL	EJK Calcium Hydroxide Cavity Liner
19 Mar 1982	K820284	ROOT CANAL FILLING RESIN	KIF Root Canal Filling Resin
11 Mar 1982	K820389	A DENTAL AMALGAM ALLOY (UNNAMED	EJJ Amalgam Alloy
2 Mar 1982	K820328	NICKEL-BASED DENTAL CASTING ALLOY	EJH Base Metal Alloy
24 Feb 1982	K813550	HYBRID DENTAL PRODUCT	EBH Resin Impression Tray Material
7 Jan 1982	K813357	CAULK OPAQUER	EBF Resin Tooth Shade Material
31 Dec 1981	K812858	CHEMFIL	EMA Dental Cement
21 Sep 1981	K810913	CAVITY VARNISH	LBH Cavity Varnish
23 Jul 1981	K811258	BASE METAL ALLOY	EJH Base Metal Alloy
5 May 1981	K811023	ROOT CANAL KIT	ELC Ultrasonic Scaler
4 Mar 1981	K810096	PORCELAIN POWDER FOR CLINICAL USE	EIH Porcelain Powder
14 Jan 1981	K802975	ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE	EBF Resin Tooth Shade Material
12 Nov 1980	K802562	PRISMA SEAL	EBC Pit and Fissure Sealant and Conditioner
10 Oct 1980	K802362	ALGINATE IMPRESSION MATERIAL	ELW Impression Material
16 Sep 1980	K802125	ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE	EBF Resin Tooth Shade Material
16 Sep 1980	K801588	CAULK PRISMA-LITE	EBZ Ultraviolet Activator for Polymerization
7 Aug 1980	K801732	PRISMA-FIL	EBF Resin Tooth Shade Material
21 Jul 1980	K801587	ASH BLUEPRINT ALGINATE IMPRESSION MATER.	ELW Impression Material
21 Jul 1980	K801548	PERF-LOCK IMPRESSION TRAY	EHY Preformed Impression Tray
20 May 1980	K801093	PRISMA-BOND	KLE Resin Tooth Bonding Agent
20 May 1980	K801092	PRISMA-FILL	EBF Resin Tooth Shade Material
17 Mar 1980	K800166	DENTSPLY DENTURE CLEANER	JER Mechanical Denture Cleaner
12 Mar 1980	K800400	MAXUM DENTURE RESIN	EBI Rebasing Repairing Relining Denture Resin
4 Jan 1980	K792245	TEETH, DENTURE, PLASTIC	ELM Teeth Plastic Denture
30 Nov 1979	K792042	DENTURE BASE RESIN	EBI Rebasing Repairing Relining Denture Resin
26 Feb 1979	K790112	MOBILE UNITS, I,II,III,IV	EIA Operative Dental Unit
26 Jan 1979	K782068	MVS UNIT, MODEL SEU-8 AND DEU-8, 80	EHZ Oral Cavity Evacuator
20 Dec 1978	K781777	ABRASIVE WHEELS	EJQ Polishing Agent Wheel
27 Sep 1978	K781488	MVS-MODEL SEU-6, DEU-6	EHZ Oral Cavity Evacuator
31 Aug 1978	K781151	REPROSIL	ELW Impression Material
14 Jun 1978	K780786	DENTURE RELINE MATERIAL	EBI Rebasing Repairing Relining Denture Resin
15 Mar 1978	K780217	ANTERIORS AND POSTERIORS, PLASTIC	ELM Teeth Plastic Denture
16 Aug 1977	K771176	GOTHIC ARCH TRACING	KZO Arch Tracing Ink
15 Jul 1977	K771179	BIOBOND MASTER STAIN AND GLAZE KIT	ELL Porcelain Teeth
5 Apr 1977	K770599	NUVA-LITE II PHOTO-CURE UNIT	EBZ Ultraviolet Activator for Polymerization
10 Jan 1977	K770009	BIOBOND C&B POST SOLDER	EJT Gold-Based Noble Metal Alloy
23 Dec 1976	K761275	AIROTOS LF HANDPIECE	DZA Intraoral Dental Drill
15 Oct 1976	K760783	BIOBOND-CROWN & BRIDGE CERAMIC BONDING	EJS Alloy Other Noble Metal

Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (55), B.J.M. Laboratories Ltd (3), China Dental Outsourcing Inc (2), DCI International LLC (1), Five Star Orthodontic Laboratory & Supply, Inc. (1), Ivoclar Vivadent, AG (1).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.