meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
2006-11-14

Clearances · page 49 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062403 IMAX CEPH DIGITAL X-RAY SENSOR Owandy MUH Class II 2006-11-14
K062064 RIVA BOND LC Southern Dental Industries, Inc. EMA Class II 2006-11-09
K062733 TOMAS PIN SD 6, 8, AND 10 MM Dentaurum OAT Class II 2006-11-09
K062409 K-ETCHANT GEL Kuraray Medical, Inc. EBF Class II 2006-11-08
K062886 ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 CAO Group, Inc. EBC Class II 2006-11-06
K062343 GRANDIO FLOW TRY-IN Voco GmbH EBF Class II 2006-11-02
K062030 US SYSTEM Osstem Implant Co., Ltd. DZE Class II 2006-11-02
K062713 ADHESIVE DC ACTIVATOR Ivoclar Vivadent, Inc. KLE Class II 2006-11-02
K062740 JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU Jindell Medical Instruments Co., Ltd. EFB Class I 2006-11-02
K062876 PRIMACONNEX CERAMIC ABUTMENTS Lifecore Biomedical, Inc. NHA Class II 2006-11-01
K062051 SS SYSTEM Osstem Implant Co., Ltd. DZE Class II 2006-11-01
K060889 SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE Pentron Clinical Technologies KIF Class II 2006-10-27
K062735 TUTU 7, MODEL IV-T22 Invisible Technology Co., Ltd. EBZ Class II 2006-10-27
K063110 CST61 HIGH SPEED TURBINE HANDPIECE Shanghai Dental Instrument Factory EFB Class I 2006-10-26
K062292 UNICEM 3M Espe Dental Products EMA Class II 2006-10-25
K062732 TOMAS PIN 6 MM Dentaurum OAT Class II 2006-10-25
K062695 SAGEMAX Z-BLANK Sagemax Bioceramics, Inc. EIH Class II 2006-10-20
K062156 SUPER ORTHODONTIC SCREW Osstem Implant Co., Ltd. DZE Class II 2006-10-20
K062129 P.0004 IMPLANTS Institut Straumann AG DZE Class II 2006-10-20
K062418 K-SPRAY, MODEL 085-2715 Scican EFB Class I 2006-10-19
K062519 NEXUS 3 Kerr Corporation EMA Class II 2006-10-19
K061359 DENSHIELD TREATMENT FOR SENSITIVE TEETH Novamin Technology, Inc. LBH Class II 2006-10-18
K062305 CLARITY MODIFIED CERAMIC BRACKETS 3M Unitek NJM Class II 2006-10-18
K063007 POWERTOME PERIOTOME Westport Medical, Inc. EKX Class I 2006-10-17
K062846 COLLAGEN DENTAL MEMBRANE III Collagen Matrix, Inc. NPL Class II 2006-10-13
K062157 CONFORM Apex Dental Materials, Inc. EBF Class II 2006-10-13
K061847 ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S Zimmer Dental, Inc. NHA Class II 2006-10-12
K062881 COLLAGEN DENTAL MENBRANE - CONFORMABLE II Collagen Matrix, Inc. NPL Class II 2006-10-11
K061804 ZERION ALPHA, ; ZERION BETA Etkon International GmbH EIH Class II 2006-10-06
K062529 BELMAX CM MODEL X168 Takara Belmont USA, Inc. MUH Class II 2006-10-05
K061997 PREMIER SELF-ETCHING ENAMEL SEALANT Premier Dental Products Co. EBC Class II 2006-10-04
K061998 PREMIER SELF-ETCHING BOND ENHANCER Premier Dental Products Co. KLE Class II 2006-10-04
K062344 GRANDIO SEAL Voco GmbH EBC Class II 2006-10-02
K061319 SPECTRA SYSTEM Implant Direct, LLC DZE Class II 2006-09-29
K061851 ZIRKONZAHN ICE Zirkonzahn GmbH EIH Class II 2006-09-29
K061906 CLEARFIL CERAMIC PRIMER Kuraray Medical, Inc. EBF Class II 2006-09-28
K062382 CLEARFIL DC BOND Kuraray Medical, Inc. KLE Class II 2006-09-27
K062410 CLEARFIL ESTHETIC CEMENT & DC BOND Kuraray Medical, Inc. EMA Class II 2006-09-26
K061507 SONICWELD RX ENDOBROW FIXATION KLS-Martin L.P. JEY Class II 2006-09-21
K061658 SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L Dentall Corp. EBZ Class II 2006-09-18
K061860 CLEARFIL MAJESTY ESTHETIC Kuraray Medical, Inc. EBF Class II 2006-09-18
K061695 LED PROLUX 770 Peng Lim Enterprise Co., Ltd. EBZ Class II 2006-09-14
K061809 ARTEGRAL IMCROWN Merz Dental GmbH EBG Class II 2006-09-13
K062509 INCORIS ZI Sirona Dental Systems GmbH EIH Class II 2006-09-12
K061611 BOSWORTH DENTIN RESIN Harry J. Bosworth Co. KLE Class II 2006-09-11
K061410 SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT Zimmer Dental, Inc. DZE Class II 2006-09-08
K052968 MODIFICATION TO: ORLUS MINI SCREW Ortholution Co., Ltd. DZE Class II 2006-09-08
K061688 ANTI-SNORING / SLEEP APNEA DEVICE Tomed Dr. Toussaint GmbH LRK Class II 2006-09-08
K061717 ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED Zimmer Dental, Inc. DZE Class II 2006-09-08
K062506 INCORIS AL Sirona Dental Systems GmbH EIH Class II 2006-09-08
K061735 INFIBRA, MODEL 1200 Global Dental Products, Inc. EBI Class II 2006-09-08
K061664 FORMCORE DC, MODEL 28-700100 J. Morita USA, Inc. EBF Class II 2006-09-08
K062504 CERAMAX Alphadent Co., Ltd. EIH Class II 2006-09-05
K062281 ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 Zimmer Dental, Inc. DZE Class II 2006-09-05
K061781 MULTILINK SPRINT Ivoclar Vivadent, Inc. EMA Class II 2006-09-05
K061797 SM IMPLANT SYSTEMS Dio Department Dsi, Inc. DZE Class II 2006-09-01
K060882 EXCEL BOND DC, MODEL 28-200100 J. Morita USA, Inc. KLE Class II 2006-09-01
K062299 SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT Synthes (Usa) MQN Class II 2006-08-31
K060720 CURATIVE DENTAL ACRYLIC TEETH Curative, LLC ELM Class II 2006-08-25
K061701 HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) J. Morita USA, Inc. EFA Class I 2006-08-25
K060958 STRAUMANN NARROW NECK IMPLANTS Straumann USA DZE Class II 2006-08-24
K061529 PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM Nobel Biocare AB NHA Class II 2006-08-23
K061478 PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS Nobel Biocare AB NHA Class II 2006-08-21
K053555 ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L Guilin Woodpecker Medical Instrument Co., Ltd. ELC Class II 2006-08-21
K062389 Z-BLOCK, MODELS 20/19, 40/19, 55/19 Foundation Milling Centre EIH Class II 2006-08-21
K061448 BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES Bonart Co., Ltd. ELC Class II 2006-08-17
K061397 ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M Ace Surgical Supply Co., Inc. OAT Class II 2006-08-16
K061581 EXCEL HIGH SPEED DENTAL HANDPIECE Orthosource, Inc. EFA Class I 2006-08-16
K061176 STRAUMANN DENTAL IMPLANTS Institut Straumann AG DZE Class II 2006-08-11
K061477 MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS Nobel Biocare AB NHA Class II 2006-08-11
K061335 ENHANCE DENTAL IMPLANT SYSTEM Coastal Biocare DZE Class II 2006-08-09
K061500 SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS Sic Invent AG DZE Class II 2006-08-08
K061904 COMPUDENT STA Milestone Scientific, Inc. EJI Class II 2006-08-08
K062219 PRODRIVE SYSTEMS REPLACEMENT TURBINE Prodrive Systems, Inc. EFB Class I 2006-08-04
K061383 BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS B.T.I. Biotechnology Institute, Sl. EJL Class I 2006-08-03
K061230 VECTORS TEMPORARY ANCHORAGE SYSTEM Sybron Dental Specialties OAT Class II 2006-08-03
K061266 ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR Ortho Organizers, Inc. OAT Class II 2006-07-31
K061981 SURPASS Apex Dental Materials, Inc. KLE Class II 2006-07-31
K053654 ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE Atlantis Components, Inc. NHA Class II 2006-07-31
K061807 SPI ART ABUTMENTS Thommen Medical AG NHA Class II 2006-07-31
K061580 ECLIPSE WAX REMOVER Dentsply International EBI Class II 2006-07-28
K052957 IMPLANTIUM PROSTHETICS Dentium Co., Ltd. NHA Class II 2006-07-27
K061501 FLEXO DENTAL RESIN MATERIAL Aci, Inc. EBI Class II 2006-07-26
K061823 ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE Voco GmbH EBC Class II 2006-07-21
K061969 PREFORMANCE POSTS AND TEMPORARY CYLINDERS Implant Innovations, Inc. NHA Class II 2006-07-21
K061530 MD-TEMP Meta Biomed Co., Ltd. EBG Class II 2006-07-21
K053060 TCS UNBREAKABLE Thermoplastic Comfort Systems, Inc. EBI Class II 2006-07-20
K052574 COMPACT PLUS - EXTREME - PERFECT PLUS J.O. Suarez & Cia, Ltda EIA Class I 2006-07-17
K060891 VIRTUAL Ivoclar Vivadent, Inc. ELW Class II 2006-07-17
K061535 GC XLC-100 CAPSULE GC America, Inc. EMA Class II 2006-07-14
K053578 SCORPION ULTRASONIC SCALING INSERTS Scorpion ELC Class II 2006-07-14
K061732 TAP-T Airway Management, Inc. LRK Class II 2006-07-12
K061267 SIMULATE, COLOR CHANGE ALGINATE Cavex Holland BV ELW Class II 2006-07-10
K061481 GRENGLOO Ormco Corp. DYH Class II 2006-07-06
K061284 I-CAT SCANNER Imaging Sciences Intl., Inc. MUH Class II 2006-07-03
K061003 SFB & CFB IMPLANTS Nobel Biocare AB DZE Class II 2006-06-30
K053373 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE Atlantis Components, Inc. NHA Class II 2006-06-30
K061271 ERCH ARCH BAR, MODEL 38-690-00 KLS-Martin L.P. DYX Class II 2006-06-30
K052513 BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 Delta Enterprise Corporation KKO Class II 2006-06-28
K061043 ZIMMER CONTOUR RESTORATIVE SYSTEM Zimmer Dental, Inc. NHA Class II 2006-06-27

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