meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1994-12-29

Clearances · page 86 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945244 PULP CANAL SEALER EWT Sybron Dental Specialties, Inc. EMA Class II 1994-12-29
K944271 DENTAL OPERATIVE UNIT ACCESORIES Dci Intl. EIA Class I 1994-12-29
K945723 OPULENT 76 AND 83 Aalba Dent, Inc. EJT Class II 1994-12-29
K945714 VERABOND III Aalba Dent, Inc. EJH Class II 1994-12-29
K940776 KREATIV MODEL KV-1 Kreativ, Inc. KOJ Class II 1994-12-21
K942562 PROSTHOFLEX Knopf Assoc, Inc. EBI Class II 1994-12-20
K945462 SUPER POLI-GRIP DENTURE ADHESIVE CREAM Block Drug Company, Inc. KOT Class I 1994-12-20
K944084 JENERIC/PENTRON P0WERED TOOTHBRUST Jeneric/Pentron, Inc. JEQ Class I 1994-12-20
K945173 PULPDENT HARDSHELL Pulpdent Corp. EBF Class II 1994-12-15
K925678 ATHENA HIGH SPEED HANDPIECE Athena Technology, Inc. EFB Class I 1994-12-15
K944575 AQUAFRESH PLAQUE FIGHTING GUM Smithkline Beecham Consumer Healthcare Products EJR Class I 1994-12-15
K944848 THE VIVACARE T.P.S. PROBE Rms Div. EIX Class I 1994-12-14
K945113 PULPDENT CERVICAL RESTORATIVE Pulpdent Corp. EBF Class II 1994-12-14
K945058 PULPDENT MICROFILLED ANTERIOR COMPOSITE Pulpdent Corp. EBF Class II 1994-12-14
K945018 PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL Pulpdent Corp. EBF Class II 1994-12-14
K945056 PULPDENT RESIN CEMENT Pulpdent Corp. EBF Class II 1994-12-14
K945112 PULPDENT DUAL CURE UNFILLED BONDING RESIN Pulpdent Corp. KLE Class II 1994-12-14
K942826 ORTHODONITC METAL REINFORCED PLASTIC BRACKET Gac Intl., Inc. DYW Class II 1994-12-14
K945057 PULPDENT HYBRID ANTERIOR COMPOSITE Pulpdent Corp. EBF Class II 1994-12-14
K944934 POLYURETHANE SOLUTION 29% W/W Knowell Therapeutic Technologies,Inc. LBH Class II 1994-12-09
K944659 PRODIGY Sybron Dental Specialties, Inc. EBF Class II 1994-12-08
K944356 KIS-II IMPLANT SYSTEM/DRILLS Implant Center of the Palm Beaches DZE Class II 1994-12-05
K944702 PROCERA ALL-CERAMIC PORCELAIN Nobelpharma USA, Inc. EIH Class II 1994-12-02
K944981 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM 3M Company EBG Class II 1994-12-02
K945077 INSTRUMENT,FILLING,PLASTIC,DENTAL Worldwide Dental, Inc. EKJ Class I 1994-11-30
K943540 SURGICAL CUTTING BURS Stryker Corp. DZJ Class II 1994-11-30
K944945 PULPDENT CALCIUM HYDROXIDE PREPARATIONS Pulpdent Corp. EJK Class II 1994-11-30
K945200 FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES Procter & Gamble Co. KOO Class I 1994-11-30
K944286 METAL-LINED TRANSCEND CERAMIC BRACKET Unitek Corp. DYW Class II 1994-11-29
K944416 LIFE Sybron Dental Specialties, Inc. EJK Class II 1994-11-29
K944162 DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM Teledyne Water Pik EAG Class II 1994-11-29
K923395 VIDENT IMPAC IMPLANT ACCESSORIES Vident DZE Class II 1994-11-22
K933360 GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER Miles Inc., Dental Products KLE Class II 1994-11-22
K944256 OKTAS INTRA-ORAL DENTAL CAMERA Oktas EIA Class I 1994-11-22
K941247 VIDENT IMPAC INFINITE POSITION ABUTMENT Vident DZE Class II 1994-11-21
K940998 IMPAC TORQUE WRENCH Vident DZE Class II 1994-11-21
K925849 ZEST IMPLANT ANCHOR Zest Anchors, Inc. DZE Class II 1994-11-18
K944889 ALLROUND 4 J.F. Jelenko & Co., Inc. EJT Class II 1994-11-17
K941575 SMOOTH FIT Hi-Tec Implants DZE Class II 1994-11-17
K943642 HERCULITE XR & XRV Sybron Dental Specialties, Inc. EBF Class II 1994-11-17
K944888 MEDALIST J.F. Jelenko & Co., Inc. EJT Class II 1994-11-07
K944887 EUREKA PLUS J.F. Jelenko & Co., Inc. EJT Class II 1994-11-07
K944679 JEL 96 J.F. Jelenko & Co., Inc. EJT Class II 1994-11-07
K942851 SMILE INTEGRATED PROPHYLAXIS PASTE RINGS Germiphene Corp. EJR Class I 1994-11-04
K942808 TYPE I GLASS IONOMER CEMENT Mion International Corp. EMA Class II 1994-11-03
K943486 ORAFIX SPECIAL DENTURE ADHESIVE Smithkline Beecham Corp. KOO Class I 1994-11-03
K944557 DW250 #91 Rms Div. EJT Class II 1994-11-03
K944480 SEALAPEX Sybron Dental Specialties, Inc. EMA Class II 1994-11-03
K943820 STAT PAK Magnum Instruments, Inc. EKJ Class I 1994-11-02
K944572 V-DELTA N (V-DELTA LOY), AUROFLUID 2PF Metalor EJT Class II 1994-11-02
K926378 THERMABOND V Dentecon, Inc. EJT Class II 1994-11-01
K926376 MION 525 Mion International Corp. EMA Class II 1994-10-21
K943370 IMPULSE SEALER PRODUCT LINE Ultradent Products, Inc. EJI Class II 1994-10-21
K944565 KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) KLS-Martin L.P. JEY Class II 1994-10-18
K944560 MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST KLS-Martin L.P. JEY Class II 1994-10-18
K942670 GC PATTERN RESIN GC America, Inc. EBG Class II 1994-10-18
K944561 MICRO OSTEOSYNTHESIS SYSTEM (1.0) KLS-Martin L.P. JEY Class II 1994-10-18
K943351 MAUNAL DISPOSABLE DENTAL INSTRUMENTS Magnum Instruments, Inc. EKJ Class I 1994-10-07
K942946 OSTEOGRAF/D-100 HYDROXYLAPATITE Ceramed Corp. LYC Class II 1994-10-05
K940785 MOUTH PROPS Worldwide Dental, Inc. EIF Class I 1994-10-05
K943334 HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT Jay H. Geller DZC Class I 1994-10-05
K943346 MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM Patton, Boggs & Blow JEY Class II 1994-10-04
K943348 KLS CHIN PLATE SYSTEM Patton, Boggs & Blow JEY Class II 1994-10-04
K943345 MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM Patton, Boggs & Blow JEY Class II 1994-10-04
K943347 KLS MINI OSTEOSYNTHESIS SYSTEM Patton, Boggs & Blow JEY Class II 1994-10-04
K941620 LORENZ SURGICAL CYLINDER DENTAL IMPLANT Biomet, Inc. DZE Class II 1994-09-29
K941619 LORENZ SURGICAL THREADED DENTAL IMPLANT Biomet, Inc. DZE Class II 1994-09-29
K941621 LORENZ SURGICAL FINNED DENTAL IMPLANT Biomet, Inc. DZE Class II 1994-09-29
K943584 PRESTERILIZED ENDODONTIC FILES Dentsply Intl. EKJ Class I 1994-09-21
K933532 SELF TAPPING DENTAL IMPLANT SYSTEM Implant Support Systems, Inc. DZE Class II 1994-09-21
K933639 IMKB CONTRA-ANGLES Micro-Mega EGS Class I 1994-09-21
K942992 ROYAL SHIELD RUBBER DAMS Elastomade Accessories Sdn Bhd EIE Class I 1994-09-21
K935443 ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS Osada Electric Co., Ltd. DZH Class II 1994-09-20
K943372 CALCIUM HYDROXIDE PASTE Ultradent Products, Inc. EJK Class II 1994-09-19
K925481 STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT Steri-Oss, Inc. DZE Class II 1994-09-19
K925555 STERI-OSS THREADED TPS HEX SERIES IMPLANT Steri-Oss, Inc. DZE Class II 1994-09-19
K943841 SOPHOS DENTAL DIAMOND Sophos Technologic DZP Class I 1994-09-16
K943388 GC SURFLEX F GC America, Inc. ELW Class II 1994-09-12
K943182 ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR Oral-B Laboratories EFS Class I 1994-09-09
K942520 E-VAC-U-ACCESSORIES Bull Frog Mfg. Co. EIA Class I 1994-09-09
K943757 SOLDER AUROLITE REPAIR Argen Precious Metals, Inc. EJT Class II 1994-09-09
K943738 OPTIBOND-D Sybron Dental Specialties, Inc. KLE Class II 1994-09-09
K943755 SOLDER AUROLITE CB Argen Precious Metals, Inc. EJT Class II 1994-09-09
K935896 THIXOFLEX Zhermack Dental Production ELW Class II 1994-09-09
K941476 MODEL 2600 PROCART Compressor Technologies, Ltd. EIA Class I 1994-09-02
K942634 PEMBUSH Crossroads Trading Co. JEQ Class I 1994-09-02
K943838 ARGESOL #760 Argen Precious Metals, Inc. EJT Class II 1994-09-02
K935906 RANIR PLAX RX Ranir/Dcp Corp. EAX Class I 1994-09-02
K943582 SOFTWEAR PORCELAIN SYSTEM Dentsply Intl. EIH Class II 1994-08-29
K943779 ARGESOL #720 Argen Precious Metals, Inc. EJT Class II 1994-08-29
K940914 NEW LUTING CEMENT MATERIAL (NLC) Dentsply Intl. EMA Class II 1994-08-29
K923889 O BUTMENT ES IMPLANT O Co., Inc. DZE Class II 1994-08-29
K940908 DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS Dunhall Pharmaceuticals, Inc. DZP Class I 1994-08-29
K942742 ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV Wallace A. Erickson & Co. DYH Class II 1994-08-29
K932168 HEXLOCK/HEXLOCK SCREW Imtec Corp. DZE Class II 1994-08-24
K935886 ELITE LIGHT BODY Zhermack Dental Production ELW Class II 1994-08-23
K935887 ELITE REGULAR BODY Zhermack Dental Production ELW Class II 1994-08-23
K942212 OSTEOGRAF/LD-300 HYDROXYLAPATITE Ceramed Corp. LYC Class II 1994-08-23
K931242 ELITE PUTTY HARD Zhermack Dental Production ELW Class II 1994-08-23
K935889 OCCLUFAST Zhermack Dental Production ELW Class II 1994-08-23

12,679 clearances in the Dental panel. Data: openFDA.