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Dental

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

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RecordFirmDate
TRC-PEX, RADIC-SEALER (K132123)Km Corporation2014-03-20
DIGORA OPTIME (K133231)Instrumentarium Dental, Palodex Group OY2014-03-20
INTRA-LOCK DENTAL IMPLANTS (K133613)Intra-Lock International, Inc.2014-03-20
STRYKER PEDIATRIC MANDIBLE DISTRACTOR (K133398)Stryker2014-03-20
SATURN DENTAL IMPLANT (K131258)Cortex Dental Implants Industries , Ltd.2014-03-17
CERCOM II CEMENT (K132393)Denali Corporation2014-03-14
TRINIA (K133608)Bicon, LLC2014-03-14
CERASMART (K133824)GC America, Inc.2014-03-14
NEWTRON P5 XS B.LED (K132322)Satelec - Acteon Group2014-03-11
MM-SEAL (K123276)Micro-Mega Societe Anonyme2014-03-10
NEWTRON P5, NEWTRON P5 B.LED (K132267)Satelec - Acteon Group2014-03-10
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT (K133527)Osstem Germany GmbH2014-03-07
FLASH AR; FLASH AR QUICK (K133436)3M Deutschland GmbH2014-03-07
OPTIGLAZE COLOR (K133836)GC America, Inc.2014-03-06
FLASH BITE (K133400)3M Espe AG2014-03-06
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED (K133339)Zimmer Dental, Inc.2014-03-04
SFI-ANCHOR (K130618)Cendres & Metaux SA2014-03-03
SFI-BAR IMPLANT ABUTMENTS (K132814)Sterngold Dental, LLC2014-02-25
SMILEBOND SYSTEM (K132599)Millennium Company, LLC2014-02-25
NEODENT IMPLANT SYSTEM (K133696)Jjgc Industria E Comercio DE Materiais Dentarios S2014-02-25
NEODENT IMPLANT SYSTEM (K133510)Jj Industria E Comercio DE Materiais Dentarios SA2014-02-24
MATRICEL DENTAL BARRIER MEMBRANE (K123697)Matricel GmbH2014-02-24
AIR-FLOW HANDY 3.0 PERIO (K132480)E.M.S Electro Medical Systems S.A2014-02-24
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, (K132219)Straumann USA, LLC2014-02-21
AXIOM REG (K131066)Anthogyr Sas2014-02-21
DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL (K132212)Hager& Meisinger GmbH2014-02-14
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS (K132426)Sylphar N.V.2014-02-14
ADHESE UNIVERSAL (K133318)Ivoclar Vivadent, AG2014-02-11
CONTROL SEAL (K130485)Voco GmbH2014-02-11
NEXXZR(TM)T AND NEXXZR(TM)S (K130991)Sagemax Bioceramics, Inc.2014-02-10
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (K132356)Scican GmbH2014-01-31
VITA SUPRINITY(R) (K132070)Vita Zahnfabrik H.Rauter GmbH & Co.2014-01-31
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION (K132746)Nobel Biocare USA, LLC2014-01-30
JUVORA DENTQAL DISC (K132725)Juvora2014-01-23
VSP SYSTEM (K133907)Medical Modeling, Inc.2014-01-22
EDS ULTRASONIC TIPS (K132609)Essential Dental Systems, Inc.2014-01-22
ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (K131644)Dentsply International, Inc.2014-01-22
A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM (K132125)A.B. Dental Devices , Ltd.2014-01-21
ENDOCENTER (K131151)Satelec - Acteon Group2014-01-16
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES (K132844)Straumann USA, LLC2014-01-15
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (K132984)Ivoclar Vivadent, Inc.2014-01-14
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (K130235)Hans Biomed Corp.2014-01-10
ET PROSTHETIC SYSTEM (K130662)Osstem Implant Co., Ltd.2014-01-10
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K121235)Stryker2014-01-09
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE (K130476)Dental Morelli2014-01-08
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS (K133049)Biomet 3i2014-01-08
FUSION SINGLE LINK (K132923)Angelus Industria DE Productos Odontologicos SA2014-01-03
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM (K130572)Implant Direct Sybron Manufacturing, LLC2013-12-24
K-ETCHANT SYRINGE; NEEDLE TIP (E) (K133078)Kuraray Noritake Dental, Inc.2013-12-20
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL (K131510)Blackwell Device Consulting2013-12-20
MULTI ANGLED ABUTMENT SYSTEM (K132067)Hiossen, Inc.2013-12-20
VAPOR CERAMIC BRACKET (K132368)Orthodontic Design and Production, Inc.2013-12-19
TI STAR IMPLANT SYSTEM (K132992)T-Plus Implant Tech. Co., Ltd.2013-12-18
LUCO HYBRID OSA APPLIANCE (K130797)Luco Hybrid Osa Appliance, Inc.2013-12-18
COPRA TEMP PMMA-DISK (K131664)White Peaks Dental Systems GmbH & Co. KG2013-12-18
AIDI DENTAL IMPLANT SYSTEM (K123861)Aidi Biomedical, LLC2013-12-12
AVINENT DENTAL IMPLANT SYSTEM (K121873)Avinent Implant System S.L.2013-12-11
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT (K132519)Stryker2013-12-06
PIEZON 250 (K132445)E.M.S Electro Medical Systems S.A2013-12-06
INNO SLA SUBMERGED IMPLANT SYSTEM (K132242)Cowellmedi Co., Ltd.2013-12-06
STARCERAM (K133213)H.C. Starck Ceramics GmbH2013-12-05
BOND APATITE (K121177)Augma Biomaterials, Ltd.2013-12-05
UD IMPLANT SYSTEM (K131682)Medimecca Co., Ltd.2013-12-05
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK (K132748)Shofu Dental Corporation2013-12-04
NEWTRON BOOSTER (K131997)Satelec - Acteon Group2013-11-26
PIEZON 150 (K132443)E.M.S Electro Medical Systems S.A2013-11-22
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM (K132258)Zimmer Dental, Inc.2013-11-19
IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS (K130829)Iq Implants , Ltd.2013-11-14
MERIDIAN (K131753)Ab Ardent2013-11-14
ANKER DENTAL IMPLANT SYSTEM (K131165)Alliance Global2013-11-14
BECE CAD ZIRKON HT+ (K132102)Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO2013-11-12
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K130419)Genoray Co., Ltd.2013-11-06
ENAMELAST (K132109)Ultradent Products Inc. / Oratech, LLC2013-11-01
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND (K132450)Kuraray Noritake Dental, Inc.2013-11-01
RAYSCAN A-EXPERT (K131693)Ray Co., Ltd.2013-11-01
CLEARPATH ALIGNER (K123514)Qserve America, Inc.2013-11-01
OSSEOFUSE DENTAL IMPLANT SYSTEM (K131748)Osseofuse, Inc.2013-10-31
IPS E.MAX CAD ABUTMENT SOLUTIONS (K132209)Ivoclar Vivadent, AG2013-10-31
LUNA DENTAL IMPLANT SYSTEM (K123155)Shinhung Mst Co., Ltd.2013-10-31
DIPLOMAT (K130534)Diplomat Dental S.R.O.2013-10-30
GUIDOR BIORESORBABLE MATRIX BARRIER (K132325)Sunstar Americas, Inc.2013-10-29
OSSEOSPEED PROFILE EV (K130999)Dentsply Implants Manufacturing GmbH2013-10-25
ULTRACEM (K132255)Ultradent Products Inc. / Oratech, LLC2013-10-24
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS (K122295)Core 3D Protech, S.L.2013-10-24
NEO DENTA ZIRCONIA (K130198)Neo Group Limited2013-10-21
ASA ORAL APPLIANCES (K130504)American Sleep Association2013-10-18
BIOROOT RCS (K130601)Novocol, Inc.2013-10-17
KATANA ZIRCONIA (K131534)Kuraray Noritake Dental, Inc.2013-10-11
MTM(R) CLEAR ALIGNER (K132145)Dentsply International, Inc.2013-10-11
R7 (K130834)Cefla S.C.2013-10-08
BEAUTIFIL BULK FLOWABLE (K132141)Shofu Dental Corporation2013-10-03
LEDEX (K131042)Dentmate Technology Co. , Ltd.2013-10-03
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING (K132600)Biomet Microfixation2013-10-02
WIRED MOUTH PROTECTOR (WMP) (K131396)Elba Laboratories, Inc.2013-09-30
MASTERTORQUE LUX 8900 L (K130560)Kaltenbach & Voigt GmbH2013-09-27
EASY-GRAFT (K131385)Degradable Solutions AG2013-09-27
I-GEN (K131289)Megagen Implant Co., Ltd.2013-09-25
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES (K130455)Dentalez Group, Stardental Division2013-09-25
DIAGNOCAM (K123402)Kaltenbach & Voigt GmbH2013-09-24
CRYSTAL ULTRA (K130654)Dental Laboratory Milling Supplies, LLC (Dlms)2013-09-24
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