meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1996-10-02

Clearances · page 79 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963185 ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER Electronic Control Concepts EHD Class II 1996-10-02
K962680 HYUNJAE DENTAL IMPRESSION MATERIALS Hyunjae Corp. ELW Class II 1996-09-30
K962747 PULPDENT ENDODONTIC POST CEMENT KIT Pulpdent Corp. EMA Class II 1996-09-30
K961387 MT-X The Emerging Technologies Group DZE Class II 1996-09-25
K961386 MT-2A The Emerging Technologies Group DZE Class II 1996-09-25
K961382 MT1A The Emerging Technologies Group DZE Class II 1996-09-25
K961383 MT1 The Emerging Technologies Group DZE Class II 1996-09-25
K962979 S-53 INTRORAL DENTAL SYSTEM Del Medical Systems Corp. DZA Class I 1996-09-25
K961385 MT-3A The Emerging Technologies Group DZE Class II 1996-09-25
K961384 MT-2 The Emerging Technologies Group DZE Class II 1996-09-25
K962878 TARGIS SYSTEM Ivoclar North America, Inc. EBF Class II 1996-09-25
K962542 AIR MOTOR HANDPIECE TN-102 Nsk Nakanishi, Inc. EFB Class I 1996-09-24
K961826 DIGIPAN Trophy Radiologie EHD Class II 1996-09-23
K962494 PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE Usbiomaterials Corp. LYC Class II 1996-09-20
K962465 TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS Implant Innovations, Inc. DZE Class II 1996-09-20
K962540 E-TYPE CONTRA ANGLE NAC-E Nsk Nakanishi, Inc. EGS Class I 1996-09-12
K962428 EBS (ESPE BONDING SYSTEM) Espe GmbH & Co. Kg. KLE Class II 1996-09-12
K962543 ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU Nsk Nakanishi, Inc. EFB Class I 1996-09-11
K962442 HYTAC APLITIP/HYTAC OSB Espe GmbH & Co. Kg. EBF Class II 1996-09-11
K962440 PERTAC II/PERTAC II APLITIP Espe GmbH & Co. Kg. EBF Class II 1996-09-11
K961420 PROSTYLE COMPACT Planmeca Oy EIA Class I 1996-09-10
K963078 STERI-OSS TEMPORARY IMPLANT CEMENT Steri-Oss, Inc. EMA Class II 1996-09-10
K962516 TAP ANTI-SNORING DEVICE Nellcor Puritan Bennett, Inc. LRK Class II 1996-09-10
K962403 NOBLEPHARMA WIDE ACCESSORIES Nobelpharma USA, Inc. DZE Class II 1996-09-06
K962741 TRI-PHASIX CHROMATIC ALGINATE Parkell, Inc. ELW Class II 1996-09-06
K962449 OSTEO COMPACTION KIT Steri-Oss, Inc. DZE Class II 1996-09-06
K962946 ORTHO-ONE Bisco, Inc. DYH Class II 1996-09-03
K962192 SUNRISE CURING LAMP Sunrise Technologies, Inc. EBF Class II 1996-09-03
K962383 PULPDENT RESILUTE II Pulpdent Corp. EMA Class II 1996-09-03
K962885 SEALEX EXTRA ROOT CANAL SEALER Baladent KIF Class II 1996-08-30
K962272 SYNTHES MANDIBLE DISTRACTOR Synthes (Usa) MQN Class II 1996-08-30
K962106 SPLINE DENTAL IMPLANT SYSTEMS Calcitek, Inc. DZE Class II 1996-08-29
K962405 SANICURE DISPOSABLE CURING PROBE Efos Canada, Inc. EBF Class II 1996-08-29
K962665 A-DEC SELF-CONTAINED WATER SYSTEM A-Dec, Inc. EIA Class I 1996-08-22
K961861 VARIOUS DENTAL IMPLANTS WITH COVER SCREWS Implant Management of America DZE Class II 1996-08-22
K962838 PERMARIDGE SYRINGE Ceramed Corp. LYC Class II 1996-08-20
K954690 STRYKER ORAL MAX SYSTEM Stryker Corp. DZI Class II 1996-08-20
K961976 THE BIOPLATE FIXATION SYSTEM Biomedics JEY Class II 1996-08-16
K962023 PLASTIC PROTECTION HEALING CAPS The Straumann Co. DZE Class II 1996-08-15
K961893 DURAFLOR Pharmascience, Inc. LBH Class II 1996-08-14
K952614 JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL Dentsply Intl. ELW Class II 1996-08-13
K962785 3M DENT SYSTEM 3M Company KLE Class II 1996-08-12
K961472 DENTAL DAM SILICONE Worldwide Dental, Inc. EIE Class I 1996-08-07
K962333 V.R.S. DENTURE RESIN MATERIAL Vident EBI Class II 1996-08-07
K960297 MANDIBULAR BONE DISTRACTOR II Howmedica Corp. MQN Class II 1996-08-06
K952927 IMPACT AIR 45 4-HOLE Palisades Pharmaceutics, Inc. EFB Class I 1996-08-06
K962071 SPIRIT S1/S2 Pelton & Crane Co. EIA Class I 1996-08-06
K962456 SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH Ivoclar North America, Inc. ELM Class II 1996-08-06
K960398 STERI-OSS APICAL IMPLANT Steri-Oss, Inc. DZE Class II 1996-08-01
K960886 STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS Steri-Oss, Inc. DZE Class II 1996-08-01
K962786 OSTEOGRAF STAINLESS STEEL SYRING Ceramed Corp. LYC Class II 1996-08-01
K962515 KERR ADVANCED ADHESIVE Kerr Dental Materials Center KLE Class II 1996-08-01
K960417 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS Implant Innovations, Inc. DZE Class II 1996-08-01
K962527 GENERAL PURPOSE DENTAL TRAY Medcare Medical Group, Inc. EIA Class I 1996-08-01
K961735 ACTA Satelec EBZ Class II 1996-07-31
K962445 ARTHROCARE DENTAL ELECTROSURGERY SYSTEM Arthrocare Corp. EKZ Class II 1996-07-30
K962017 HYPODERMIC JET INJECTION APPARATUS American Jet Injector Corp. EGM Class II 1996-07-26
K961704 MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM Dentatus USA , Ltd. ELS Class II 1996-07-26
K962337 ELITYS OR ELITYS-E Trophy Radiologie EHD Class II 1996-07-25
K962120 TOMOGRAPH ACCESSORIES Steri-Oss, Inc. EHD Class II 1996-07-25
K962325 QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) Sterngold/Implamed EJT Class II 1996-07-24
K962326 STERNGOLD BIO-5 (1127210) Sterngold/Implamed EJT Class II 1996-07-24
K954432 CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM Crystal Medical Technology DZE Class II 1996-07-24
K962324 STERNGOLD U-CPF METAL ALLOY (1067800) Sterngold/Implamed EJS Class II 1996-07-24
K962304 STERNGOLD BIO-4 Sterngold/Implamed EJS Class II 1996-07-23
K962374 FIBER-SPLINT ML MULTILAYER Polydentia USA EBI Class II 1996-07-22
K962130 BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE Nobelpharma USA, Inc. DZE Class II 1996-07-22
K960696 PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM Ultradent Products, Inc. KLE Class II 1996-07-18
K961457 SUBLIMINATOR Healex Products, Inc. EJI Class II 1996-07-18
K962348 PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT Dentsply Intl. KLE Class II 1996-07-18
K961736 17 ANGULATED ABUTMENT Nobelpharma USA, Inc. NHA Class II 1996-07-18
K962065 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE 3M Company EMA Class II 1996-07-18
K962303 STERNGOLD CF Sterngold/Implamed EJT Class II 1996-07-18
K962301 STERNGOLD G-HARD METAL ALLOY The Stern Metals Co., Inc. EJS Class II 1996-07-18
K962302 PEGASUS DENTAL ALLOY Sterngold/Implamed EJT Class II 1996-07-18
K961720 CERAMCO CROWNS AND BRIDGES Eric S. Small, Dds EJH Class II 1996-07-18
K961754 SAFETY RELEASE MODULE G & H Wire Co. DZB Class II 1996-07-10
K961728 MIRUSCONE ABUTMENT SYSTEM Nobelpharma USA, Inc. NHA Class II 1996-07-10
K961737 CERA ONE ABUTMENT SYSTEM Nobelpharma USA, Inc. DZE Class II 1996-07-10
K961434 VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM Vident EBF Class II 1996-07-08
K961448 FUJI IX GP GC America, Inc. EMA Class II 1996-07-08
K961648 THE WAND Spintech, Inc. EJI Class II 1996-07-05
K962277 SELF CURE BONDING AGENT Dent Zar, Inc. KLE Class II 1996-07-03
K960667 CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE Wallace A. Erickson & Co. EBF Class II 1996-07-02
K962297 VIVAGLASS CEM Ivoclar North America, Inc. EMA Class II 1996-06-26
K961421 SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM Synthes (Usa) JEY Class II 1996-06-26
K961995 QUICKSPLINT Heraeus Kulzer, Inc. EBI Class II 1996-06-26
K961910 VIVAGLASS FIL Ivoclar North America, Inc. EMA Class II 1996-06-26
K961494 SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE Micro-Mega Societe Anonyme EGS Class I 1996-06-26
K961199 BOSWORTH TEMPORARY RESIN Harry J. Bosworth Co. EBG Class II 1996-06-25
K933705 LAMINOSS DENTAL IMPLANT Impladent , Ltd. DZE Class II 1996-06-24
K954281 PANASIL IMPRESSION MATERIAL Roydent Dental Products, Inc. ELW Class II 1996-06-24
K960634 TITANIUM HEALING CAPS The Straumann Co. DZE Class II 1996-06-18
K960899 IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW Imcor DZE Class II 1996-06-17
K961409 PORTA'PURE/DENTAL Water Solution Technologies EIA Class I 1996-06-12
K961822 WET-PREP Bisco, Inc. KLE Class II 1996-06-11
K961714 ASEPTYLUM, UNI-CARRIER Distriflor S.A. EKJ Class I 1996-06-10
K961574 TONGUE SCRAPPER U.S. Dentek Corp. LCN Class I 1996-06-10
K954605 ACE CYLINDER DENTAL IMPLANT Ace Surgical Supply Co., Inc. DZE Class II 1996-06-05
K961020 STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS Steri-Oss, Inc. DZE Class II 1996-06-05

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