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Dental

12,644 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
AMARIS/AMARIS FLOW (K071386)Voco GmbH2007-06-05
VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 (K070991)Vita2007-06-01
OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS (K062636)Implant Innovations, Inc.2007-06-01
LUBRINA, MODEL HIM-1 (K070074)J. Morita USA, Inc.2007-05-31
ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 (K071235)Zimmer Dental, Inc.2007-05-30
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR (K070327)Sybron Dental Specialties, Inc.2007-05-25
ASCENT DENTAL CLEANSER (K070070)CAO Group, Inc.2007-05-25
DIO PROTEM IMPLANT SYSTEM (K070568)Dio Department Dsi, Inc.2007-05-25
ENDOSSEOUS DENTAL IMPLANT SYSTEM (K070905)Southern Implants, Inc.2007-05-24
MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM (K061323)Bioinfera, Inc.2007-05-23
SEA2 SELF ETCH ADHESIVE (K070956)3M Espe Dental Products2007-05-22
EZ PLUS IMPLANT SYSTEM (K070562)Megagen Co., Ltd.2007-05-18
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN (K071267)Novamin Technology, Inc.2007-05-18
GVC-100 (K070840)GC America, Inc.2007-05-15
INTERGRO ORAL (K070147)Biomet 3i2007-05-14
COLORISE (K070677)Zhermack S.P.A.2007-05-11
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE (K062572)Custom Scientific2007-05-11
ADHESE ONE (K070646)Ivoclar Vivadent, Inc.2007-05-11
RTR SYRINGE (K063634)Septodont2007-05-11
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH (K070591)Union Dental S.A./Unidesa.Odi2007-05-11
WN SYNOCTA GOLD ABUTMENT (K063789)Straumann USA2007-05-10
FUSION RESIN CEMENT AND CORE KIT (K070702)Denali Corporation2007-05-10
AURAVUE PIT & FISSURE SEALANT (K070693)Denali Corporation2007-05-09
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 (K071106)Ultradent Products, Inc.2007-05-08
ACQUASEAL BENZ (K070289)Acquamed Technologies, Inc.2007-05-04
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 (K071055)Ultradent Products, Inc.2007-05-03
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT (K070307)Dentsply International, Inc.2007-05-02
ULTRASONIC SCALER, VARIOS 560 (K062731)Nakanishi, Inc.2007-05-01
3I OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341)Implant Innovations, Inc.2007-04-30
ZIRBLOCK (K070537)Cdl Technologies, Inc.2007-04-30
PRESSX ZR (K070772)Wieland Dental + Technik GmbH & Co. KG2007-04-30
EASY CURING PEN-STYLE LED CURING LIGHT (K063659)Dent Corp. Research & Development2007-04-30
OSSEOSPEED 4.0S-6MM, MODEL 24619 (K063779)Astra Tech, Inc.2007-04-27
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 (K070413)CAO Group, Inc.2007-04-26
PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). (K070664)Progeny, Inc.2007-04-26
FREEALGIN (K070700)Zhermack S.P.A.2007-04-25
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 (K062834)Genoss Co., Ltd.2007-04-24
OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE (K063286)Implant Innovations, Inc.2007-04-24
RETROPAN CCD-TWAIN-USB (K070535)Video Dental Concepts, Inc.2007-04-24
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 (K070022)Mis Implants Technologies , Ltd.2007-04-20
LEONE MONOIMPLANT FOR O-RING OVERDENTURE (K070483)Leone S.P.A.2007-04-19
THE FUGO BLADE FOR DENTISTRY (K063468)Medisurg , Ltd.2007-04-18
SPI VECTODRILL CERAMIC DRILLS (K070290)Thommen Medical AG2007-04-17
CYRTINA SYSTEM (K063842)Oratio B.V.2007-04-17
NANO COMPOSITE (K070583)Cosmedent, Inc.2007-04-16
MEISINGER BENEX, MODEL BE001 (K062130)Hager& Meisinger GmbH2007-04-16
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM (K063790)Synthes (Usa)2007-04-16
ODONCER (K062102)Teknimed, S.A.2007-04-16
GC MI PASTE PLUS (K070854)GC America, Inc.2007-04-12
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING (K061277)Straumann USA2007-04-12
ASC-12 PIEZOELECTRIC SCALER (K070866)Aseptico, Inc.2007-04-11
MODIFICATION TO: VELSCOPE (K070523)Led Dental, Inc.2007-04-05
KRYSTAL-X WIFI (K070505)Owandy2007-04-05
ZYGOMA IMPLANT (IMMEDIATE FUNCTION) (K070182)Nobel Biocare AB2007-04-04
RESCUE INTERNAL IMPLANT SYSTEM (K063216)Megagen Co., Ltd.2007-04-02
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 (K063321)Neks Technologies, Inc.2007-03-30
ALPHA BIO BONE FIXATION SCREW SYSTEM (K063769)Alpha-Bio Tec , Ltd.2007-03-30
TOKUYAMA BOND FORCE (K070215)Tokuyama Dental Corporation2007-03-30
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM (K063874)Blue Sky Bio, LLC2007-03-29
COE SOFT (K070697)GC America, Inc.2007-03-29
COE COMFORT (K070698)GC America, Inc.2007-03-29
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127)Kevin Vu, Dds2007-03-29
DIGORA PCT/DIGIPOD (K070304)Soredex Palodex Group OY2007-03-27
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM (K063770)Alpha-Bio Tec , Ltd.2007-03-26
ZIRBLANK-PS AND ZIRBLANK-FS (K070045)Acucera, Inc.2007-03-26
PAINT- ON POLISH AGENT (K070306)Dentsply International, Inc.2007-03-22
CLEARFIL MAJESTY ESTHETIC PLT (K070325)Kuraray Medical, Inc.2007-03-21
TOTAL ETCH BONDING AGENT (K063444)Dmg USA, Inc.2007-03-20
CONICAL ANGLED ABUTMENT (K063403)Implant Innovations, Inc.2007-03-20
ALPHA BIO DENTAL IMPLANT SYSTEM (K063364)Alpha-Bio Tec , Ltd.2007-03-14
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE (K070538)Dentsply Intl.2007-03-14
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM (K061881)Takiron Co., Ltd.2007-03-14
GRADIA DIRECT X (K070190)GC America, Inc.2007-03-12
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084)Est. Anthogyr2007-03-08
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) (K063149)T.O.A.D.S., LLC2007-03-08
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K063473)Synthes (Usa)2007-03-08
OPTI (K063646)Camsight Co., Inc.2007-03-07
ALPHA-CORE DC (K070191)Dental Technologies, Inc.2007-03-07
ZIRCONIA IMPLANT (K061971)Nobel Biocare AB2007-03-06
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE (K063734)Atlantis Components, Inc.2007-03-02
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM (K063792)Osteomed LP2007-03-02
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W (K070373)Apoza Enterprise Co., Ltd.2007-03-02
CREATION CP-ZI PORCELAIN (K070114)Jensen Industries, Inc.2007-03-01
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT (K062197)Atlantis Components, Inc.2007-02-28
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM (K062789)Synthes (Usa)2007-02-27
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 (K063592)Nobel Biocare AB2007-02-27
GC FUJI IX GP EXTRA (K070319)GC America, Inc.2007-02-26
CERTAIN PREVAIL DENTAL IMPLANT (K061629)Implant Innovations, Inc.2007-02-23
NANOTITE DENTAL IMPLANTS (K062432)Implant Innovations, Inc.2007-02-22
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL (K063596)Novabone Products, LLC2007-02-22
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (K063704)Beks Incorporated2007-02-20
DOWN PAK (K070246)Endo Twinn B.V.2007-02-16
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 (K063523)Zimmer Dental, Inc.2007-02-16
BETA-POWDER (K063236)Brainbase Corporation2007-02-16
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT (K062069)Atlantis Components, Inc.2007-02-14
EXCEL CONTRA ANGLE HANDPIECE (K061897)Orthosource, Inc.2007-02-14
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM (K061252)Primus Consulting2007-02-12
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (K070287)Photonic Optische Gerate GmbH & Cokg2007-02-12
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K063549)Novabone Products, LLC2007-02-12
CLEARFIL MAJESTY POSTERIOR (K063595)Kuraray America, Inc.2007-02-09
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