FDA 510(k) Applications Submitted by DENTSPLY INTL.

FDA 510(k) Number Submission Date Device Name Applicant
K960028 01/02/1996 ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM DENTSPLY INTL.
K980543 02/12/1998 DENOPTIX BARRIER ENVELOPE (SIZE 0-4) DENTSPLY INTL.
K992610 08/04/1999 GENDEX 765DC, MODEL 110-0154 DENTSPLY INTL.
K964659 11/20/1996 ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM DENTSPLY INTL.
K070019 01/03/2007 CARRARA VOLUMIA DENTSPLY INTL.
K070538 02/26/2007 XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE DENTSPLY INTL.
K050750 03/23/2005 LC BRACKET ADHESIVE SYSTEM DENTSPLY INTL.
K050880 04/06/2005 DYRACT EXTRA RESTORATIVE DENTSPLY INTL.
K061427 05/23/2006 PRE-IMPRESSION CONDITIONING SOLUTION DENTSPLY INTL.
K051463 06/03/2005 XENO ADHESIVE WITH ACTIVATOR DENTSPLY INTL.
K051462 06/03/2005 MODIFICATION TO: CERCON BASE DENTSPLY INTL.
K051707 06/27/2005 ECLIPSE BONDING AGENT DENTSPLY INTL.
K052334 08/26/2005 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 DENTSPLY INTL.
K072730 09/26/2007 FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS DENTSPLY INTL.
K042905 10/21/2004 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY DENTSPLY INTL.
K043247 11/23/2004 DUCERA ALLCERAM DENTSPLY INTL.
K123615 11/23/2012 IRIS - HIGH STRENGTH GLASS CERAMIC DENTSPLY INTL.
K973221 08/27/1997 COMPOSITE 168 RESTORATIVE SYSTEM DENTSPLY INTL.
K981620 05/06/1998 MTA MATERIAL II DENTSPLY INTL.
K974140 11/03/1997 ADHESIVE HYBRID IONOMER CEMENT DENTSPLY INTL.
K032904 09/17/2003 ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 DENTSPLY INTL.
K984387 12/08/1998 R-30 AESTHETIC RESTORATIVE DENTSPLY INTL.
K982007 06/08/1998 TRUBYTE DENTURE BOND DENTURE BONDING AGENT DENTSPLY INTL.
K980332 01/28/1998 MTA MATERIAL DENTSPLY INTL.
K970123 01/14/1997 DENTSPLY CAVITRON SPS SCALER SYSTEM DENTSPLY INTL.
K000169 01/20/2000 NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN DENTSPLY INTL.
K970342 01/29/1997 CAVITRON JET WITH SPS SYSTEM DENTSPLY INTL.
K960548 02/08/1996 AH PLUS ROOT CANAL SEALER DENTSPLY INTL.
K040375 02/17/2004 IDEAL 1 ORTHODONTIC BAND CEMENT DENTSPLY INTL.
K040420 02/18/2004 DUCERAM PLUS CERAMIC SYSTEM DENTSPLY INTL.
K040421 02/18/2004 DUCERAGOLD PORCELAINS DENTSPLY INTL.
K040635 03/10/2004 CARRARA INTERACTION CERAMIC SYSTEM DENTSPLY INTL.
K000996 03/28/2000 TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND DENTSPLY INTL.
K040895 04/06/2004 INTEGRITY TEMPORARY CEMENT DENTSPLY INTL.
K040906 04/07/2004 CALIBRA CEMENT DENTSPLY INTL.
K031145 04/10/2003 ESTYLUS ELECTRIC MOTOR SYSTEM DENTSPLY INTL.
K041141 04/30/2004 DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 DENTSPLY INTL.
K971603 05/01/1997 STERILE SUREFLEX FILES AND INSTRUMENTS DENTSPLY INTL.
K971606 05/01/1997 STERILE FLEXOFILE FILES AND INSTRUMENTS DENTSPLY INTL.
K021416 05/03/2002 AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL.
K021413 05/03/2002 AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL.
K021410 05/03/2002 AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL.
K041272 05/12/2004 DYRACT CEM PLUS CEMENT DENTSPLY INTL.
K971869 05/21/1997 FINESSE ALL-CERAMIC SYSTEM DENTSPLY INTL.
K011560 05/21/2001 TRUBYTE DENTURE BASE RESIN SYSTEM DENTSPLY INTL.
K021805 06/03/2002 SEAL & PROTECT PROTECTIVE SEALANT DENTSPLY INTL.
K952614 06/05/1995 JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL DENTSPLY INTL.
K991909 06/07/1999 DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT DENTSPLY INTL.
K972234 06/16/1997 RCT GEL ROOT CANAL THERAPY GEL DENTSPLY INTL.
K962348 06/18/1996 PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT DENTSPLY INTL.
K031932 06/23/2003 FLUORIDE VARNISH DENTSPLY INTL.
K041707 06/23/2004 CERCON CERAM EXPRESS CERAMIC SYSTEM DENTSPLY INTL.
K982318 07/02/1998 SPECTRUM 800 CURING UNIT DENTSPLY INTL.
K992516 07/28/1999 DYRACT SEAL COMPOMER PIT & FISSURE SEALANT DENTSPLY INTL.
K992518 07/28/1999 PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTL.
K992519 07/28/1999 NRC NON-RINSE CONDITIONER DENTSPLY INTL.
K032317 07/28/2003 ORION GX ALLOY DENTSPLY INTL.
K032316 07/28/2003 ORION E ALLOY DENTSPLY INTL.
K032361 07/31/2003 ENDOPURE ROOT CANAL CLEANSER DENTSPLY INTL.
K002387 08/04/2000 COMFORT CONTROL SYRINGE SYSTEM DENTSPLY INTL.
K042178 08/11/2004 ORTHODONTIC CERAMIC BRACKETS DENTSPLY INTL.
K992822 08/23/1999 SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE DENTSPLY INTL.
K022796 08/23/2002 CERCON CERAM S PORCELAIN DENTSPLY INTL.
K973235 08/28/1997 DYRACT AP RESTORATIVE DENTSPLY INTL.
K992956 09/02/1999 LUCITONE FRS FLEXIBEL DENTAL RESIN DENTSPLY INTL.
K032892 09/17/2003 MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM DENTSPLY INTL.
K964040 10/08/1996 TRUBYTE SOFT RELINE SYSTEM DENTSPLY INTL.
K964046 10/09/1996 DENTSPLY PRECISION TORQUE SYSTEM DENTSPLY INTL.
K974035 10/24/1997 CENTURY ALLOY DENTSPLY INTL.
K983966 11/06/1998 NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN DENTSPLY INTL.
K033553 11/10/2003 PFZ PORCELAIN SYSTEM DENTSPLY INTL.
K964525 11/12/1996 PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR DENTSPLY INTL.
K023776 11/12/2002 XENO III DENTAL ADHESIVE DENTSPLY INTL.
K033667 11/21/2003 CARRARA PRESS SYSTEM DENTSPLY INTL.
K033703 11/25/2003 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE DENTSPLY INTL.
K024133 12/16/2002 CLS-2000 UNIT DENTSPLY INTL.
K014188 12/21/2001 NEW PROPHY POWDER DENTSPLY INTL.
K970433 02/05/1997 AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL.
K960823 02/29/1996 PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT DENTSPLY INTL.
K961291 04/04/1996 FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS DENTSPLY INTL.
K031461 05/08/2003 CARRIER TIPS DENTSPLY INTL.
K981965 06/04/1998 FLOWABLE COMPOSITE DENTSPLY INTL.
K972573 07/10/1997 LIQCRYLIC PRO DENTAL RESIN DENTSPLY INTL.
K012720 08/15/2001 TULSA CONTRA ANGLES DENTSPLY INTL.
K973781 10/03/1997 AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL DENTSPLY INTL.
K973782 10/03/1997 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL.
K003518 11/15/2000 RAPIDD HIGHSPEED DENTAL HANDPIECE DENTSPLY INTL.
K003921 12/20/2000 DYRACT CEM LCI COMPOMER DENTSPLY INTL.
K982395 07/09/1998 DYTRACT FLOW RESTORATIVE DENTSPLY INTL.
K982394 07/09/1998 PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTL.
K982564 07/23/1998 DELTON FS DIRECT DELIVERY SYSTEM DENTSPLY INTL.
K000112 01/14/2000 ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 DENTSPLY INTL.
K994211 12/14/1999 ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 DENTSPLY INTL.
K994285 12/20/1999 ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH DENTSPLY INTL.


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