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Dental

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

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RecordFirmDate
BOND BONE (K083858)Augma Biomaterials, Ltd.2009-03-17
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH (K090597)Pascal Co., Inc.2009-03-16
BEL-CYPHER, MODEL Y977 (K090020)Takara-Belmont Co., Ltd.2009-03-13
ROOT CANAL XR (K083062)S & C Polymer GmbH2009-03-12
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM (K083388)Synthes (Usa)2009-03-12
ADX4000-L, DX3000-L (K083532)Dexcowin Co., Ltd.2009-03-10
ZQUIET MOUTHPIECE (K090503)Sleeping Well, LLC2009-03-10
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT (K083796)Miltex, Inc.2009-03-09
DENOVISMED DENTAL IMPLANT SYSTEMS (K083543)Denovis Medical, LLC2009-03-06
INCLUSIVE TITANIUM ABUTMENT BLANKS (K083192)Inclusive Dental Solutions2009-03-04
NANGEL (K083005)Teknimed, S.A.2009-03-04
PHOGLASS CEM (K083766)S & C Polymer GmbH2009-03-02
NEOSS ACCESS ABUTMENTS (K081851)Neoss, Ltd.2009-03-02
PRODRIVE LINE OF DENTAL HANDPIECES (K090369)Prodrive Systems, Inc.2009-02-27
BIOCRYL X (K083479)Great Lakes Orthodontics, Ltd.2009-02-27
MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS (K090260)Straumann Manufacturing, Inc.2009-02-26
STRAUMANN DENTAL IMPLANT SYSTEM (K083550)Straumann USA2009-02-26
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM (K083324)Zest Anchors, Inc.2009-02-25
BIOACTYS (K082286)Graftys2009-02-24
PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES (K083101)Sable Industries, Inc.2009-02-23
FLOWTAIN & FLOWTAIN LV (K083051)Reliance Orthodontic Products, Inc.2009-02-20
PERIOGENIX (K083516)Oroscience, Inc.2009-02-20
STRAUMANN DENTAL IMPLANT SYSTEM (K081419)Institut Straumann AG2009-02-20
EMS AIR-FLOW MASTER (K082791)E.M.S Electro Medical Systems S.A2009-02-18
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM (K083252)Dentalez Group, Stardental Division2009-02-18
TRIMIRA IDENTAFI 3000 (K090135)Remicalm, LLC2009-02-17
NOBELACTIVE 8.5 MM & 18.0 MM (K083205)Nobel Biocare AB2009-02-13
BIFIX SE (K083438)Voco GmbH2009-02-13
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS (K073121)Nubrace, Inc.2009-02-12
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX (K083742)Collagen Matrix, Inc.2009-02-12
NEOSS PROACTIVE IMPLANT (K083561)Neoss, Ltd.2009-02-11
DLMS-ZIRBLOCKS (K082137)Dental Milling Laboratory Supplies (Dlms)2009-02-10
FLUOROCORE 2 (K083326)Dentsply International, Inc.2009-02-10
TEMPOSIL 2 (K083304)Coltene/Whaledent AG2009-02-06
CLEARCORRECT (K082556)Clearcorrect, Inc.2009-02-06
PORTABLE X-RAY SYSTEM, MODEL DXR -1 (K082875)Exaro Co., Ltd.2009-02-05
MS SYSTEM (K083067)Osstem Implant Co., Ltd.2009-02-02
KAT IMPLANT SYSTEM (K083544)Kat Implants, LLC2009-02-02
CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS (K083496)Altatec GmbH2009-01-30
AIR SONIC SCALER (K083059)Dpm USA Corp.2009-01-30
STER-MATE STERILE LAVAGE KIT (K082973)Dentsply Interntional2009-01-29
PITT-EASY DENTAL IMPLANT SYSTEM (K083297)Sybron Implant Solutions GmbH2009-01-28
ACRYLIC HERBST SPLINT APPLIANCE (K083209)Specialty Appliance Works, Inc.2009-01-27
CERCOM CEMENT (K083398)Denali R&D Corporation2009-01-26
ZMATCH BLOCK (K083201)Dentaim Co., Ltd.2009-01-26
BIO-SCREEN (K082668)Addent, Inc.2009-01-23
VALO, MODEL 5919 (K083647)Ultradent Products, Inc.2009-01-23
CLEAR BRAVO (K083473)Denali R&D Corporation2009-01-22
CFS FLEXIBLE (K081537)Comfort and Flexible Systems2009-01-22
CARE3 PLUS (K081811)Nakanishi, Inc.2009-01-21
IBOND TOTAL ETCH (K083652)Heraeus Kulzer,GmbH2009-01-21
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT (K082115)S & C Polymer GmbH2009-01-15
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 (K082716)A-Dec, Inc.2009-01-15
SWISSPLANT DENTAL IMPLANT SYSTEM (K081396)Implant Direct, LLC2009-01-14
SPECTRA-SYSTEM ABUTMENTS 2008 (K081101)Implant Direct, LLC2009-01-14
VOCO PROFLUORID L (K083036)Voco GmbH2009-01-12
PANASIL INITIAL CONTACT AND PANASIL TRAY (K083701)Kettenbach GmbH & Co. KG2009-01-09
MASTERGRAFT RESORBABLE CERAMIC GRANULES (K082917)Medtronic Sofamor Danek2009-01-09
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (K082827)A-Dec, Inc.2009-01-07
IROOT BP, MODEL IRBP 4609 (K082943)Innovative Bioceramix, Inc.2009-01-06
BITTAR ZIRCONIA BLOCKS (K082652)Bittar Zirconia Block, LLC2008-12-30
HELIODENT PLUS (K083344)Sirona Dental Systems GmbH2008-12-23
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT (K083474)Zimmer Dental, Inc.2008-12-23
ENDOSSEOUS DENTAL IMPLANT SYSTEM (K082651)Southern Implants, Inc.2008-12-22
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS (K082639)Zimmer Dental, Inc.2008-12-19
ADIN DENTAL IMPLANTS SYSTEM (K081751)Adin Dental Implants System, Ltd.2008-12-19
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE (K083610)3M Company2008-12-17
A-DEC 334/335 DELIVERY SYSTEM (K082985)A-Dec, Inc.2008-12-17
MIS CREST WIDENER (K080458)Mis - Implant Technologies , Ltd.2008-12-17
PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 (K082180)Angelus Industria DE Productos Odontologicos2008-12-17
INVISALIGN SYSTEM (K081960)Align Technology2008-12-17
DISTRAX (K080542)John W. King2008-12-15
TRIMIRA OCS 3000 (K082603)Remicalm, LLC2008-12-12
BEAUTIBOND (K082744)Shofu Dental Corp.2008-12-11
HERCULITE ULTRA (K082671)Sybron Dental Specialties2008-12-11
TEMPORARY COLD.V AND SELF-CURE DENTINE (K082700)Major Prodotti Dentari S.P.A.2008-12-09
FLEXITIME BITE (K082591)Heraeus Kulzer, Inc., Dental Products Division2008-12-05
KODAK 9500 (K082972)Trophy2008-12-05
OMNI-TIGHT (K082749)Basic Dental Implant Systems, Inc.2008-12-04
LEDEX, MODEL: WL-070 (K082408)Dentmate Technology Co. , Ltd.2008-12-03
ZIOCERA & CONVERTIBLE SYSTEM (K081786)Osstem Implant Co., Ltd.2008-12-02
GC AADVA ZR DISK (K082740)GC America, Inc.2008-11-26
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 (K082200)SOADCO, S.L.2008-11-25
ORLUS MINI SCREW (K082838)Ortholution Co., Ltd.2008-11-25
MAJOR.REPAIR (K082153)Major Prodotti Dentari S.P.A.2008-11-25
FUTURABOND M/FUTURABOND M SINGLE DOSE (K082753)Voco GmbH2008-11-24
TDS ABUTMENT (K081460)Pou YU Biotechnology Co., Ltd.2008-11-21
STOMA BONE BLOCK SCREW (K080430)Storz AM Mark GmbH2008-11-21
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT (K081287)Den-Mat Holdings, LLC2008-11-21
VERICORE IMPLANT ABUTMENTS (K082299)Whip-Mix Corp.2008-11-20
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP (K083100)Nobel Biocare USA, LLC2008-11-19
LANG DENTAL ACRYLIC PRIMER (K081981)Lang Dental Mfg. Co., Inc.2008-11-17
GDLS-200 (K082434)GC America, Inc.2008-11-14
BONART ART-L5 LED CORDLESS CURING LIGHT (K082971)Bonart Co., Ltd.2008-11-13
BIOLOK MICRO-LOK IMPLANT SYSTEM (K081818)BioHorizons Implant Systems, Inc.2008-11-13
PROGENIX (K082463)Medtronic Sofamor Danek2008-11-10
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM (K082335)Synthes (Usa)2008-11-10
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM (K083141)Simpact, LLC2008-11-07
MOLAR IMPLANT (K081128)Nobel Biocare AB2008-11-07
IDI IMPLANT SYSTEM (K081806)Idi Biomedical, LLC2008-11-07
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