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Dental

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

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RecordFirmDate
ACCELEDENT AURA (K130643)Orthoaccel Technologies, Inc.2013-04-23
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (K121804)Itena Clinical2013-04-19
STORM MINI SCREW (K122069)Lancer Orthodontics, Inc.2013-04-11
STRAUMANN DENTAL IMPLANT SYSTEM (K123784)Straumann USA, LLC2013-04-10
CLEARFIL MAJESTY ES FLOW (K130371)Kuraray Noritake Dental, Inc.2013-04-09
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM (K123786)Stryker2013-04-09
INCORIS ZI (K123664)Sirona Dental Systems GmbH2013-04-08
HEALTHY SLEEP APPLIANCE (K123410)Healthy Sleep Dental Laboratory2013-04-05
6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM (K122198)Oco Biomedical2013-04-05
PONTIC PAINT (K130237)Reliance Orthodontic Products, Inc.2013-04-05
SIMPLI SIMPLER IMPLANT SYSTEM (K121281)Simpler Implant Solutions2013-04-05
AEI DR. TERAUCHI ULTRASONIC TIPS (K122501)American Eagle Instruments, Inc.2013-03-29
RMGI FILL (K130223)Pulpdent Corporation2013-03-29
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE (K124008)Ivoclar Vivadent, Agin2013-03-29
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM (K123512)Biodenta Swiss AG2013-03-28
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES (K123139)Asi Medical, Inc.2013-03-28
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM (K123870)Megagen Implant Co., Ltd.2013-03-27
INSIGNIA DIGICAST (K123118)Ormco Corp.2013-03-26
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM (K130221)Medimecca Co., Ltd.2013-03-21
CEREC BLOCS C IN (K123952)Sirona Dental Systems GmbH2013-03-20
DEMI ULTRA (K123468)Kerr Corporation2013-03-20
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED (K123415)Biodenta Swiss AG2013-03-19
DENTOETCH QUICKBOND BOND ACTIVATOR (K122522)Itena Clinical2013-03-19
RAYSCAN A-EXPERT (K122918)Ray Co., Ltd.2013-03-15
BEGOPAL+ (K123929)Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO2013-03-14
ORALID (K123169)Forward Science, LLC2013-03-13
BIOGENESIS IMPLANT SYSTEM (K120089)Biogenesis Co., Ltd.2013-03-13
INSIGNIA WITH ITERO (K123416)Ormco Corp.2013-03-13
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS (K122602)Nobel Biocare AB2013-03-13
SOPROCARE (K121685)Sopro2013-03-12
ORAVAN OSA (K121285)New Jersey Snoring Solutions2013-03-08
REVOIS IMPLANT SYSTEM (K113042)Riemser Arzneimittel AG2013-03-08
IMAGE WORKS PANOURA (K122806)Mic International2013-03-08
ULTRASONIC SCALER (K113717)Nakanishi, Inc.2013-03-05
DENTOCORE / DENTOCORE BODY (K121769)Itena Clinical2013-03-05
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (K122955)Wright Health Group , Ltd.2013-03-01
VITA ENAMIC STAINS (K123761)Innovation Meditech GmbH2013-03-01
VERTEX THERMOSENS RIGID (K123220)Vertex-Dental B.V.2013-03-01
REXTAR, REXTAR LCD (K122016)Meta Biomed, Inc.2013-03-01
TI-MAX Z45 (K121901)Nakanishi, Inc.2013-02-28
CLEAR ALIGNER ADHESIVE (K123348)Reliance Orthodontic Products, Inc.2013-02-28
SYNTHES PATIENT SPECIFIC PLATE (K122647)Synthes, Inc.2013-02-28
INCLUSIVE TAPERED IMPLANT SYSTEM (K121406)Prismatik Dentalcraft, Inc.2013-02-22
IRIS - HIGH STRENGTH GLASS CERAMIC (K123615)Dentsply Intl.2013-02-22
VITRO FIL LC (K123824)Dfl Industria E Comercio SA2013-02-21
PEKKTON IVORY (K123638)Cendres & Metaux SA2013-02-21
COPRANCOLOR (K123680)White Peaks Dental Systems GmbH & Co. KG2013-02-21
FIBER DISK AND BLOCK PERMANENT, TRINIA (K121735)Bioloren S.R.L.2013-02-21
FIN-S MICROIMPLANT (K120861)Creekside Orthodontics2013-02-21
SYNSPAR ADVANCED (K123613)Ardent, Inc.2013-02-20
NEXUS RMGI (K123595)Kerr Corporation2013-02-19
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC (K122894)Geistlich Pharma AG2013-02-15
VITRO MOLAR (K123826)Dfl Industria E Comercio SA2013-02-14
NEW STETIC ARTIFICIAL TEETH (K122925)New Stetic2013-02-12
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (K122065)Ormco Corp.2013-02-08
INCORIS TZI (K123545)Sirona Dental Systems GmbH2013-02-01
ULTRASONIC SCALER (K113530)Nakanishi, Inc.2013-01-31
MULTILINK AUTOMIX (K123397)Ivoclar Vivadent, AG2013-01-31
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV (K113816)GC America, Inc.2013-01-30
T3 DENTAL IMPLANT (K122300)Biomet 3i2013-01-30
INION CPS ORBITAL PLATES (K122890)Inion OY2013-01-29
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO (K123304)Ivoclar Vivadent, AG2013-01-24
POINT 500 HD POINT500C HD (K121800)Pointnix Co., Ltd.2013-01-24
OSSEOSPEED ANGLED ABUTMENT EV (K121810)Astra Tech AB2013-01-23
HERO I DENTAL IMPLANT SYSTEM (K121098)Kj Meditech Co., Ltd.2013-01-17
OCS-B (K113246)Nibec Company, Limited2013-01-16
REMESENSE FOR SENSITIVE TEETH (K122708)Sylphar N.V.2013-01-14
I.FLEX BY TCS (K123396)Thermoplastic Comfort Systems, Inc.2013-01-10
MEDTRONIC XOMED, INC. (K122391)Medtronic Xomed, Inc.2013-01-10
SOLOCEM (K121621)Coltene/Whaledent AG2013-01-08
VANTAGE MODEL V5000, V5100, V5000C, V5100C (K122643)Midmark Corp.2013-01-07
TS IMPLANT SYSTEM (K121585)Osstem Implant Co., Ltd.2013-01-07
THERASOM-CAST (K113516)Family Dental Services, P.C.2013-01-04
COLLADENTAL BARRIER (K100695)Collamatrix, Inc.2013-01-03
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (K122039)Kettenbach GmbH & Co. KG2012-12-27
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (K123419)Afp Imaging Corp.2012-12-27
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST (K120822)Institut Straumann AG2012-12-21
X-TRA BASE (K123773)Voco GmbH2012-12-21
Z-LOOK3 EVO SLM (K120793)Z-Systems AG2012-12-21
CERAMIN BRACKETS Z (K123092)Tomy, Inc.2012-12-21
SYNTEC DENTAL IMPLANT (K111189)Syntec Scientific Corp.2012-12-20
CURASAN OSSEOLIVE DENTAL (K111105)Curasan AG2012-12-20
TRAUS SIP10 (K123695)Saeshin Precision Co., Ltd.2012-12-18
NDX ABUTMENTS (K121117)National Dentex Corp2012-12-14
CONELOG IMPLANT SYSTEM (K113779)Altatec GmbH2012-12-14
EMPOWER CLEAR (K122753)American Orthodontics2012-12-14
ENAMIC (K122269)Vita Zahnfabrik H.Rauter GmbH & Co.2012-12-13
ORTHODONTIC CERAMIC BRACKETS (K123094)Tomy, Inc.2012-12-13
VEX-S 100W INTRAORAL X-RAY SYSTEM (K123493)VATECH Co., Ltd.2012-12-13
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS (K122855)Straumann USA2012-12-12
VSP SYSTEM (K120956)Medical Modeling, Inc.2012-12-12
ULTRASONIC SURGERY (K121620)Dmetec.Co., Ltd.2012-12-11
NP-CAST ABUTMENT SYSTEM (K121843)Osstem Implant Co., Ltd.2012-12-11
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID (K122421)Kuraray Noritake Dental, Inc.2012-12-11
BPA-FREE MICROHYBID COMPOSITE (K120237)Novocol, Inc.2012-12-11
MTA2 ROOT AND PULP MATERIALS (K122892)Avalon Biomed, Inc.2012-12-11
ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS (K122268)Dentsply International2012-12-11
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS (K121391)Prismatik Dentalcraft, Inc.2012-12-10
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) (K123273)Temrex Corp.2012-12-07
DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) (K122582)Denterprise International, Inc.2012-12-07
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