meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
1998-11-09

Clearances · page 72 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983266 FIBREKOR POST SYSTEM Jeneric/Pentron, Inc. ELR Class I 1998-11-09
K983283 SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM Signet Radiology, Inc. MUH Class II 1998-11-06
K981526 ACE ALVEOLAR DISTRACTOR Ace Surgical Supply Co., Inc. JEY Class II 1998-11-06
K973765 BIO-2000 Micrylium Laboratories EIA Class I 1998-11-04
K983285 ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS Engle Dental Systems EIA Class I 1998-11-04
K983247 SUPER PORCELAIN ADDMATE Noritake Co., Inc. EIH Class II 1998-11-03
K982773 QUICKSET LIQUID AND POWDER Specialites Septodont EMA Class II 1998-11-03
K981666 2.5 MM LACTOSORB SCREWS Biomet, Inc. DZL Class II 1998-11-03
K981691 SILICONE SOFT RELINE Harry J. Bosworth Co. EBI Class II 1998-11-03
K982766 PASTE OPAQUE EX-3 Noritake Co., Inc. EIH Class II 1998-10-30
K982793 PIEZO TRONIC Advanced Medical Devices, Inc. ELC Class II 1998-10-28
K983082 BEGOCER G Bego U.S.A. EJT Class II 1998-10-28
K980799 HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL Cosmedent, Inc. EBG Class II 1998-10-28
K983080 AUROLLOYD KF Bego U.S.A. EJT Class II 1998-10-28
K983081 BEGOPAL 300 Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO EJS Class II 1998-10-28
K983091 ELAN-2 Kerr Dental Materials Center EBF Class II 1998-10-28
K982604 LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. MQN Class II 1998-10-23
K983077 BIO PONTOSTAR Bego U.S.A. EJT Class II 1998-10-23
K983078 BEGOPAL Bego U.S.A. EJS Class II 1998-10-23
K983079 PLATINLLOYD 100 Bego U.S.A. EJT Class II 1998-10-23
K983057 ORTHOPHOS 5/PLUS/CD Sirona Dental Systems GmbH MUH Class II 1998-10-22
K982593 LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE Dentalez Group EFB Class I 1998-10-22
K981490 WILLI GELLER CREATION PORCELAIN Jensen Industries, Inc. EIH Class II 1998-10-22
K983018 ZINC PHOSPHATE CEMENT Medental Intl. EMA Class II 1998-10-22
K982576 FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 Friatec AG DZE Class II 1998-10-22
K982692 STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC Sterngold/Implamed EBF Class II 1998-10-22
K983037 ROEKO SEAL Roeko Ulm, Roescheisen GmbH & Co. KIF Class II 1998-10-20
K982699 UNIGRAFE Unicare Biomedical LYC Class II 1998-10-20
K982695 GC RELINE GC America, Inc. EBI Class II 1998-10-19
K982671 SECURALLOY Specialites Septodont EJJ Class II 1998-10-19
K982913 ZINFOS ZINC PHOSPHATE CEMENT Scientific Pharmaceuticals, Inc. EMA Class II 1998-10-19
K982917 B-SYSTEM SILICONE Sybron Dental Specialties, Inc. ELW Class II 1998-10-16
K982492 IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES Imcor DZE Class II 1998-10-15
K982658 KSEA ENDOSCOPES FOR DENTAL PROCEDURES KARL STORZ Endoscopy-America, Inc. EIA Class I 1998-10-15
K981565 BIOCLEAR CONCENTRATE Waggoner Product Development EIA Class I 1998-10-15
K982606 AUROFLUID CPF Metalor Dental USA Corp. EJT Class II 1998-10-15
K982895 STERNOMEGA COMPOMER CEMENT Sterngold/Implamed EMA Class II 1998-10-09
K980585 MILLENNIUM Biolase Technology, Inc. EFB Class I 1998-10-08
K973410 ULTRACAM W. Edward Johansen EIA Class I 1998-10-08
K982590 TEMPBOND CLEAR-2 Sybron Dental Specialties, Inc. EMA Class II 1998-10-08
K982564 DELTON FS DIRECT DELIVERY SYSTEM Dentsply Intl. EBC Class II 1998-10-06
K981861 LINER 1:HARD RELINE LIQUID Harry J. Bosworth Co. EBI Class II 1998-10-01
K982509 ORTHO IMPLANT AND ACCESSORIES Straumann USA OAT Class II 1998-09-30
K983161 KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC Sabre-K , Ltd. ELR Class I 1998-09-30
K982779 MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 Medental Intl. EMA Class II 1998-09-30
K982459 TEMPFIL F - 2 Sybron Dental Specialties, Inc. EBG Class II 1998-09-30
K981564 AIR TECHNIQUES' AIRDENT II Air Techniques, Inc. KOJ Class II 1998-09-24
K982400 STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT Steri-Oss, Inc. EMA Class II 1998-09-23
K982259 CHROMA ZONE COLOR STAIN Kuraray America, Inc. EBF Class II 1998-09-22
K982305 SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT Sulzer Calcitek, Inc. DZE Class II 1998-09-22
K982394 PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply Intl. KLE Class II 1998-09-21
K974399 BIO-OSS COLLAGEN Geistlich-Pharma LYC Class II 1998-09-16
K982105 ORAL POTENTIAL METER (OPM) Pertec of Wisconsin, Inc. LFC Class II 1998-09-16
K982480 PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. Dentalview, Inc. EIA Class I 1998-09-15
K981144 CLEAN SOURCE I, MODEL CS1000 Aquarius Technologies, Inc. EIA Class I 1998-09-15
K982111 VARIOUS DENTAL IMPLANTS Biotech Medical Instruments Corp. DZE Class II 1998-09-15
K982729 RENEW Bisco, Inc. EBF Class II 1998-09-15
K982318 SPECTRUM 800 CURING UNIT Dentsply Intl. EBF Class II 1998-09-15
K970321 BIO-OSS ANORGANIC BOVINE BONE Geistlich-Pharma LYC Class II 1998-09-15
K982139 BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM Bionx Implants, Inc. JEY Class II 1998-09-15
K982191 CHEMICAL CURE COMPOSITE WITH ENAMEL BOND Medental Intl. EBF Class II 1998-09-14
K982927 QUICK TAP SELF DRILLING SCREW Kinamed, Inc. DZL Class II 1998-09-08
K982665 JUMBO SILVER-REINFORCED GLASS IONOMER Centrix, Inc. EMA Class II 1998-09-08
K982616 IPS EMPRESS 2 Ivoclar North America, Inc. EIH Class II 1998-09-08
K981095 ALIGN SYSTEM Align Technology NXC Class II 1998-09-08
K982865 ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT Atrix Laboratories, Inc. NPK Class II 1998-09-08
K982117 FLUID CONTROL T.A. Coleman Ent. EIA Class I 1998-09-04
K980630 FRIALIT-2 CORABASE Friatec AG DZE Class II 1998-09-04
K982088 AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM Ortho Kinetics Corp. DZB Class II 1998-09-04
K981970 ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI Cavex Holland BV ELW Class II 1998-09-02
K982050 MODEL MS-2 HANDPIECE Parkell, Inc. EFB Class I 1998-09-02
K982645 PYRAMID Bisco, Inc. EBF Class II 1998-09-02
K982460 VIVACAP HR Ab Ardent EJJ Class II 1998-08-24
K982537 TOKUYAMA SOFRELINER Tokuyama America, Inc. EBI Class II 1998-08-24
K981923 THE SNORE PEACE The Snore Peace Group LRK Class II 1998-08-24
K982458 VIVALLOY HR Ab Ardent EJJ Class II 1998-08-24
K982461 GLASIONOMER CEMENT CX PLUS Shofu Dental Corp. EMA Class II 1998-08-24
K981937 WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM Welch Allyn, Inc. EIA Class I 1998-08-24
K982456 AMALCAP PLUS Ab Ardent EJJ Class II 1998-08-24
K982615 AIRDENT RADIANCE CURING LIGHT Air Techniques, Inc. EBZ Class II 1998-08-24
K980995 PLAQ-ATAQ-I Ethicare EFW Class I 1998-08-20
K981948 APOLLO 95E Dental/Medical Diagnostic Systems, Inc. EBF Class II 1998-08-18
K982377 OPC LOWWEAR PORCELAIN Jeneric/Pentron, Inc. EIH Class II 1998-08-18
K982395 DYTRACT FLOW RESTORATIVE Dentsply Intl. EBF Class II 1998-08-18
K981890 SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES Synthes (Usa) JEY Class II 1998-08-18
K980083 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT Implant Innovations, Inc. DZE Class II 1998-08-17
K981244 BW-1 (CODE NAME RD-0807) J.F. Jelenko & Co., Inc. EJT Class II 1998-08-13
K982229 BI-DENT Valley Forge Scientific Corp. EKZ Class II 1998-08-13
K981257 JELFINE-52 (CODE NAME RD-0901) J.F. Jelenko & Co., Inc. EJS Class II 1998-08-13
K980049 BONETRAP Bladhs Plast AB EIA Class I 1998-08-11
K981869 PRO-FLEX DISPOSABLE PROPHY ANGLE Professional Dental Mfg., Inc. EFB Class I 1998-08-11
K981808 BREATHAID TONGUE SCRAPER Breathaid, LLC LCN Class I 1998-08-11
K982164 ESTENIA Kuraray America, Inc. EBF Class II 1998-08-10
K982201 ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) Foremost Dental Mfg., Inc. EBF Class II 1998-08-10
K981663 DIGITAL DOC Digital Doc, LLC EIA Class I 1998-08-10
K981647 3M DENT II SYSTEM 3M Company EBF Class II 1998-08-09
K982129 ANTAGON PORCELAIN European Dental Imports, Inc. EIH Class II 1998-08-04
K980106 THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES Proma, Inc. EIA Class I 1998-08-03
K982664 VITA TITANIUM PORCELAIN Vident EIH Class II 1998-08-02
K981620 MTA MATERIAL II Dentsply Intl. KIF Class II 1998-07-31

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