meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
2007-03-22

Clearances · page 48 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K070306 PAINT- ON POLISH AGENT Dentsply International, Inc. EBD Class II 2007-03-22
K070325 CLEARFIL MAJESTY ESTHETIC PLT Kuraray Medical, Inc. EBF Class II 2007-03-21
K063403 CONICAL ANGLED ABUTMENT Implant Innovations, Inc. NHA Class II 2007-03-20
K063444 TOTAL ETCH BONDING AGENT Dmg USA, Inc. KLE Class II 2007-03-20
K061881 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM Takiron Co., Ltd. JEY Class II 2007-03-14
K063364 ALPHA BIO DENTAL IMPLANT SYSTEM Alpha-Bio Tec , Ltd. DZE Class II 2007-03-14
K070538 XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE Dentsply Intl. KLE Class II 2007-03-14
K070190 GRADIA DIRECT X GC America, Inc. EBF Class II 2007-03-12
K063473 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM Synthes (Usa) OAT Class II 2007-03-08
K063149 ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) T.O.A.D.S., LLC OAT Class II 2007-03-08
K070084 MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL Est. Anthogyr EFA Class I 2007-03-08
K070191 ALPHA-CORE DC Dental Technologies, Inc. EBF Class II 2007-03-07
K063646 OPTI Camsight Co., Inc. EIA Class I 2007-03-07
K061971 ZIRCONIA IMPLANT Nobel Biocare AB DZE Class II 2007-03-06
K063792 OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP MQN Class II 2007-03-02
K070373 APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W Apoza Enterprise Co., Ltd. EBZ Class II 2007-03-02
K063734 ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE Atlantis Components, Inc. NHA Class II 2007-03-02
K070114 CREATION CP-ZI PORCELAIN Jensen Industries, Inc. EIH Class II 2007-03-01
K062197 ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT Atlantis Components, Inc. NHA Class II 2007-02-28
K062789 SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM Synthes (Usa) JEY Class II 2007-02-27
K063592 ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 Nobel Biocare AB NHA Class II 2007-02-27
K070319 GC FUJI IX GP EXTRA GC America, Inc. EMA Class II 2007-02-26
K061629 CERTAIN PREVAIL DENTAL IMPLANT Implant Innovations, Inc. DZE Class II 2007-02-23
K063596 PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL Novabone Products, LLC LYC Class II 2007-02-22
K062432 NANOTITE DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2007-02-22
K063704 BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 Beks Incorporated EEG Class I 2007-02-20
K063236 BETA-POWDER Brainbase Corporation KOJ Class II 2007-02-16
K070246 DOWN PAK Endo Twinn B.V. EKM Class I 2007-02-16
K063523 ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 Zimmer Dental, Inc. DZE Class II 2007-02-16
K062069 ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT Atlantis Components, Inc. NHA Class II 2007-02-14
K061897 EXCEL CONTRA ANGLE HANDPIECE Orthosource, Inc. EGS Class I 2007-02-14
K061252 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM Primus Consulting DYH Class II 2007-02-12
K063549 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC LYC Class II 2007-02-12
K070287 PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 Photonic Optische Gerate GmbH & Cokg EBA Class I 2007-02-12
K063595 CLEARFIL MAJESTY POSTERIOR Kuraray America, Inc. EBF Class II 2007-02-09
K063386 LORENZ ORTHODONTIC ANCHORAGE SYSTEM Walter Lorenz Surgical, Inc. OAT Class II 2007-02-09
K063626 DURAFLEX Cosmetic Dental Materials, Inc. EBI Class II 2007-02-08
K063624 KAVO EVEREST C-TEMP Kavo America EBG Class II 2007-02-08
K062961 MICROLUX TRANSILLUMINATOR Addent, Inc. NTK Class II 2007-02-08
K070219 SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM Suni Medical Imaging, Inc. MUH Class II 2007-02-07
K063856 EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM Essential Dental Systems, Inc. KIF Class II 2007-02-06
K070297 CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT Dental Air Solutions of Nc, Inc. EFB Class I 2007-02-05
K063593 CLEARFIL MAJESTY FLOW Kuraray America, Inc. EBF Class II 2007-02-02
K063511 CERAMILL ZI Amann Girrbach America, Inc. EIH Class II 2007-02-02
K070001 MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE Mti Precision Products EFB Class I 2007-02-02
K063714 AXCEL FLOW Tri Dental Innovators EBF Class II 2007-01-31
K070196 FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT Hr Dental Products, Inc. EIA Class I 2007-01-26
K070019 CARRARA VOLUMIA Dentsply Intl. EIH Class II 2007-01-26
K070155 INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC Osseo Scientific, LLC EFB Class I 2007-01-25
K063604 TWINKY STAR NF Voco GmbH EBF Class II 2007-01-22
K061042 LINGLOCK Sybron Dental Specialties DYW Class II 2007-01-19
K063780 ACE BOND SE Bisco, Inc. KLE Class II 2007-01-19
K063554 MERON PLUS Voco GmbH EMA Class II 2007-01-12
K063170 TENDER FIBER Micerium S.P.A. EBI Class II 2007-01-12
K063052 LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES Walter Lorenz Surgical, Inc. JEY Class II 2007-01-12
K063121 PORTABLE X-RAY SYSTEM, MODEL PORT-X II Genoray Co., Ltd. EHD Class II 2007-01-11
K070007 SPI ELEMENT PLATFORM O 4.0 MM Thommen Medical AG DZE Class II 2007-01-10
K062176 RELIEF ACP ORAL CARE GEL Discus Dental, Inc. LBH Class II 2007-01-10
K063529 PENCURE, MODEL VL-7 J. Morita USA, Inc. EBZ Class II 2007-01-05
K063718 SFB AND CFB IMPLANTS - 5.0 PLATFORM Nobel Biocare AB DZE Class II 2007-01-05
K063181 SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes (Usa) NEI Class II 2007-01-05
K062289 BONART ART-L3 LED CURING LIGHT Bonart Co., Ltd. EBZ Class II 2007-01-03
K062355 ENA CEM Micerium S.P.A. EMA Class II 2006-12-27
K063459 CRANEX NOVUS Soredex Palodex Group OY MUH Class II 2006-12-26
K062277 ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE Atlantis Components, Inc. NHA Class II 2006-12-20
K062936 NOBELPERFECT CONICAL CONNECTION Nobel Biocare AB DZE Class II 2006-12-19
K060795 SOMNOFIT Strategic Counsel Sarl LRK Class II 2006-12-18
K062345 CERAMIC BOND Voco GmbH EBF Class II 2006-12-15
K062502 OSSPRAY CLEANING COMPOUND Ospray, Ltd. EJR Class I 2006-12-15
K062897 C-U2 Cefla S.C.R.L. EIA Class I 2006-12-14
K062333 LAIMAD Steven Lamberg, D.D.S LRK Class II 2006-12-14
K063558 PEAK SE, MODEL 5135 Ultradent Products, Inc. KLE Class II 2006-12-14
K062947 HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES Peng Lim Enterprise Co., Ltd. EFB Class I 2006-12-14
K062856 TF ROTARY NICKEL TITANIUM FILE Ormco Corp. EKS Class I 2006-12-13
K063557 PEAK BOND, MODEL 5133 Ultradent Products, Inc. KLE Class II 2006-12-12
K062951 TAP III ANTI-SNORING DEVICE Airway Management, Inc. LRK Class II 2006-12-12
K062791 USI DENTAL SCALER, 25XXX SERIES Ultrasonic Services, Inc. ELC Class II 2006-12-11
K063237 THERACAL LC Bisco, Inc. EJK Class II 2006-12-08
K063228 SURFACE COAT Kuraray America, Inc. EBD Class II 2006-12-08
K062367 MINISCREWS ANCHORING SYSTEM, M.A.S. Micerium S.P.A. DZE Class II 2006-12-08
K062566 NOBELREPLACE TAPERED CONICAL CONNECTION Nobel Biocare USA, LLC DZE Class II 2006-12-06
K063116 DEMETRON A.2 Sybron Dental Specialties EBZ Class II 2006-12-05
K062518 CELERITY Parkell, Inc. EBF Class II 2006-12-04
K063062 HKBOND 2006 Heraeus Kulzer, Inc. KLE Class II 2006-12-01
K062749 SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM Nobel Biocare AB NHA Class II 2006-11-29
K063003 AURORA Parkell, Inc. EBZ Class II 2006-11-28
K063010 REGEN BIOCEMENT Steiner Laboratories LYC Class II 2006-11-28
K062812 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N Thunder Tiger Corp. EFB Class I 2006-11-28
K062515 RETENTION FLOW OPAQUE Heraeus Kulzer,GmbH EBF Class II 2006-11-22
K061567 BIOHORIZONS CERAMIC ABUTMENT BioHorizons Implant Systems, Inc. NHA Class II 2006-11-22
K062044 THE 5.0 X 6.0MM DENTAL IMPLANT Bicon, Inc. DZE Class II 2006-11-21
K062683 ENAMEL PRO VARNISH Premier Dental Products Co. LBH Class II 2006-11-21
K062166 ENAMEL PRO Premier Dental Products Co. EJR Class I 2006-11-21
K063422 BIOAGGREGATE Innovative Bioceramix, Inc. KIF Class II 2006-11-21
K062851 OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED Osteomed LP MQN Class II 2006-11-17
K062906 ENA HFO COMPOSITE SYSTEM Micerium S.P.A. EBF Class II 2006-11-17
K062493 LAVA SOFTWARE 3M Espe AG Dental Products NHA Class II 2006-11-17
K062400 IMPRESSIX, COLORCHANGE ALGINATE Cavex Holland BV ELW Class II 2006-11-16
K063302 SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES Shanghai Dental Instrument Factory EIA Class I 2006-11-15
K062065 RIVA LUTING PLUS Southern Dental Industries, Inc. EMA Class II 2006-11-15

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