meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1993-12-10

Clearances · page 91 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K924121 STERI-OSS SCREW STYLE ITIANIUM IMPLANT Steri-Oss, Inc. DZE Class II 1993-12-10
K934773 ARGELITE A Argen Precious Metals, Inc. EJS Class II 1993-12-10
K923695 STERI-OSS SCREW STYLE CP TITANIUM IMPLANT Steri-Oss, Inc. DZE Class II 1993-12-10
K935390 SIROLUX FANTASTIC Pelton & Crane Co. EAZ Class I 1993-12-10
K934768 ARGELITE 81SF+ Argen Precious Metals, Inc. EJH Class II 1993-12-10
K925323 A-DEC 2183 DUO UNIT, CUSP A-Dec, Inc. KLC Class I 1993-12-09
K925318 A-DEC 2181 DUO UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925321 A-DEC 2146 DUO UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925320 A-DEC 2145 DUO UNIT, CUSP A-Dec, Inc. KLC Class I 1993-12-09
K925324 A-DEC 2184 DUO UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925314 A-DEC 2170 DUO UNIT CUSP A-Dec, Inc. KLC Class I 1993-12-09
K925325 A-DEC 2185 DOCTOR'S UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925319 A-DEC 2182 DOCTOR'S UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925315 A-DEC 2171 DUO UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925316 A-DEC 2172 DOCTOR'S UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925322 A-DEC 2147 DOCTOR'S UNIT A-Dec, Inc. KLC Class I 1993-12-09
K925317 A-DEC 2180 DUO UNIT, CUSP A-Dec, Inc. KLC Class I 1993-12-09
K934248 ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER Wallace A. Erickson & Co. EBI Class II 1993-12-08
K931556 ARGENCO M Argen Precious Metals, Inc. EJT Class II 1993-12-06
K933831 PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. Nu-Dent, Inc. EBI Class II 1993-12-06
K933541 GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS W. L. Gore & Associates, Inc. NPK Class II 1993-11-30
K934247 BISCO UNIVERSAL HYBRID COMPOSITE Bisco, Inc. EBF Class II 1993-11-29
K931137 DENTAL SYRINGE TIP A-Dec, Inc. ECB Class I 1993-11-29
K925629 ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT Den-Tal-Ez Mfg Co., Inc. EAZ Class I 1993-11-23
K931486 INTREX VSK INTERORAL DENTAL X-RAY UNIT Keystone X-Ray, Inc. EAP Class II 1993-11-23
K934769 ARGELITE W Argen Precious Metals, Inc. EJT Class II 1993-11-22
K924376 ROOT CANAL POST The Thera Group EBL Class I 1993-11-22
K933374 NITI COIL SPRINGS Highland Metals DZC Class I 1993-11-19
K933656 JEDENTAL PSROFILL SELF-CURE COMPOSITE Jedental Co., Inc. EBF Class II 1993-11-17
K934611 STO2P Ivoclar North America, Inc. EBF Class II 1993-11-17
K933893 VISION PROPHY PASTE WITHOUT FLUORIDE Block Drug Company, Inc. EJR Class I 1993-11-16
K933377 STAINLESS STEEL ARCHES REPACKER RELABETER Highland Metals DZC Class I 1993-11-16
K914714 BONE DRILLS OR TAPS Implant Corp. of America DZE Class II 1993-11-15
K933378 REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER Highland Metals DZC Class I 1993-11-12
K933379 STAINLESS STEEL ARCHES Highland Metals DZC Class I 1993-11-12
K933380 REVERSE SURVE NITI ARCH WIRE Highland Metals DZC Class I 1993-11-12
K933376 NITI ARCH WIRE ON A SPOOL Highland Metals DZC Class I 1993-11-12
K932511 SILICONE MIRROR Moyco Industries, Inc. EKJ Class I 1993-11-05
K932274 INTEGRAL III DENTAL IMPLANT ABUTMENT Calcitek, Inc. DZE Class II 1993-11-05
K923562 INTERGRAL III DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1993-11-05
K932529 LIGHTSPEED DENTAL HAND INSTRUMENT Lightspeed Endodontics EKS Class I 1993-11-04
K930115 PERIOGLASS Usbiomaterials Corp. LYC Class II 1993-11-04
K932012 CAPS Chemichl, Inc. ELL Class II 1993-11-03
K931808 DUCERAGOLD, DUCERATIN Degussa AG ELL Class II 1993-11-03
K933543 ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) Jedental Co., Inc. EMA Class II 1993-11-01
K933554 JEDENTAL ZINC CEMENT IMPROVED Jedental Co., Inc. EMA Class II 1993-11-01
K933547 INTRA-ORAL IRRIGATOR Parkell, Inc. ELC Class II 1993-10-20
K933150 NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE Nobelpharma USA, Inc. DZE Class II 1993-10-20
K933166 A-DEC 2611 ASSISTANT'S CART A-Dec, Inc. EIA Class I 1993-10-20
K933563 VS 1A Metalor Dental USA Corp. EJS Class II 1993-10-20
K922806 ORMCO SPORTSGUARD Ormco Corp. EJF Class I 1993-10-20
K933582 PROFILE SERIES 29 FILES Tulsa Dental Products, Ltd. EKS Class I 1993-10-20
K925767 BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. Nobelpharma USA, Inc. DZE Class II 1993-10-20
K933459 RESIMENT WITH FLUORIDE J.L. Blosser, Inc. EMA Class II 1993-10-20
K932774 DW232 #31 Invoclar North America, Inc. EJT Class II 1993-10-20
K930094 AUKUSLEEVE Aukland Medical Plastics, Inc. EJB Class I 1993-10-20
K920328 AMDENT 2030, POLISHER/SCALER Amdent AB ELC Class II 1993-10-20
K933178 GDC 3509 Deringer-Ney, Inc. EJT Class II 1993-10-14
K933167 A-DEC 2912 DUO CART A-Dec, Inc. EIA Class I 1993-10-13
K933163 A-DEC 2612 ASSISTANT'S CART A-Dec, Inc. EIA Class I 1993-10-12
K933168 A-DEC 3127 ASSISTANT'S WALLMOUNT A-Dec, Inc. EIA Class I 1993-10-12
K925487 NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS Nobelpharma USA, Inc. DZE Class II 1993-10-12
K933165 A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION) A-Dec, Inc. EIA Class I 1993-10-12
K925762 BRANEMARK SYSTEM SELF-TAPPING FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-12
K911593 STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS Steri-Oss, Inc. DZE Class II 1993-10-07
K932761 SOFT-WEAR HEADGEAR AND SAFETY MODULES Professional Positioners, Inc. DZB Class II 1993-10-07
K930128 SR SPECTRASIT, SR CHROMASIT Ivoclar North America, Inc. EBF Class II 1993-10-07
K925106 IMPLANTABLE PULSE GENERATORS Medtronic Vascular DYX Class II 1993-10-06
K925764 BRANEMARK SYSTEM 4.00 MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-05
K925765 BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-05
K925761 BRANEMARK SYSTEM 5.0 X 14MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-05
K923354 PORT OPII, PORT OPIII Mobile Dental Equipment Corp. EIA Class I 1993-10-05
K926501 BRANEMARK SYSTEM(R) - 5.5MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-05
K932492 IMPLANTOLOGY MODULE, MODEL 2175 Micro Surgical Instruments Corp. JEY Class II 1993-10-05
K925760 BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE Nobelpharma USA, Inc. DZE Class II 1993-10-05
K933309 PRINCE Goldsmith & Revere, Inc. EJJ Class II 1993-10-01
K933206 EXA BITE REGISTRATION MATERIAL GC America, Inc. ELW Class II 1993-09-29
K933083 DW247 #2 Ivoclar North America, Inc. EJT Class II 1993-09-29
K932990 ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP Oral-B Laboratories EFB Class I 1993-09-29
K925094 VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS Gendex Corp. EHD Class II 1993-09-29
K932886 ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE Wallace A. Erickson & Co. EBF Class II 1993-09-29
K933186 DW 248 #46 Ivoclar North America, Inc. EJT Class II 1993-09-29
K932824 EVACUATOR, ORAL CAVITY Den-Tal-Ez Mfg Co., Inc. EIA Class I 1993-09-28
K932839 A MANO TONGUE CLEANSER A Mano Products, Ltd. LCN Class I 1993-09-23
K930151 OMNI-MATRIX Innovative Technology , Ltd. JEP Class I 1993-09-23
K932827 ALPHA-DENT CORE BUILDUP PASTE Alpha-Dent EBF Class II 1993-09-23
K931380 WATER PIK PLUS PLAQUE CONTROL SYSTEM Teledyne Water Pik EFS Class I 1993-09-20
K931717 YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY Kaycor Intl., Ltd. EAP Class II 1993-09-20
K932794 PULPDENT SEAL-RITE LOW VISCOSITY Pulpdent Corp. EBC Class II 1993-09-20
K932791 PULPDENT EDTA PREPARATIONS Pulpdent Corp. KIF Class II 1993-09-20
K932319 ORTHODONTIC ELASTOMER Gac Intl., Inc. ECI Class I 1993-09-20
K925768 BRANEMARK SYSTEM SCREW TAP Nobelpharma USA, Inc. DZE Class II 1993-09-16
K925772 BRANEMARK SYSTEM GUIDE PINS Nobelpharma USA, Inc. DZE Class II 1993-09-16
K925770 BRANEMARK SYSTEM DRILLS AND COUNTERSINKS Nobelpharma USA, Inc. DZE Class II 1993-09-16
K925774 BRANEMARK SYSTEM HAND INSTRUMENT Nobelpharma USA, Inc. DZE Class II 1993-09-16
K925775 BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ Nobelpharma USA, Inc. DZE Class II 1993-09-16
K932154 CONQUEST CRYSTAL Jeneric/Pentron, Inc. EBF Class II 1993-09-15
K926368 APPLICATOR NOZZLE Centrix, Inc. EKJ Class I 1993-09-15
K932078 HELIOSEAL F Ivoclar North America, Inc. EBC Class II 1993-09-15
K931001 ORALIX DC Gendex Corp. EHD Class II 1993-09-14

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