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Dental

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

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RecordFirmDate
MYSTIQUE MB CERAMIC BRACKETS (K082974)Dentsply Interntional2008-11-07
MYRAY SKYVIEW (K081088)Cefla S.C.2008-11-06
GRADIA CORE (K082171)GC America, Inc.2008-10-30
DURASHIELD PLUS (K082198)Dentsply Intl., Inc.2008-10-29
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM (K073307)Bio-Technology USA, Inc.2008-10-29
MPOWRX SNORING SOLUTION (K081965)Mpowrx Health and Wellness Products, Inc.2008-10-27
TEMPORARY TOOTH REPLACEMENT (K081900)Ormco Corp.2008-10-24
EASY GLAZE (K082285)Voco GmbH2008-10-24
STRAUMANN GUIDED INSTRUMENTS (K082532)Straumann USA2008-10-21
SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM (K073645)659543 BC , Ltd.2008-10-21
G-BOND PLUS (K082768)GC America, Inc.2008-10-21
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS (K082545)Institut Straumann AG2008-10-17
CDB CLIP (K080906)Cdb Corporation2008-10-17
DENSEO FAIRY (K082158)Xpdent Corp2008-10-15
GS III FIXTURE SYSTEM (K082213)Osstem Implant Co., Ltd.2008-10-14
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT (K073368)Bicon, LLC2008-10-10
DIO SM IMPLANT SYSTEM (K080559)Dsi, Inc.2008-10-09
MAJOR.BASE 20 (K081884)Major Prodotti Dentari S.P.A.2008-10-08
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS (K081666)Astra Tech, Inc.2008-10-07
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT (K082071)Adpharma, Inc.2008-10-02
DYNAMATRIX (K082058)Cook Biotech, Inc.2008-10-02
STRAUMANN WN CARES TITANIUM ABUTMENT (K082764)Institut Straumann AG2008-10-01
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM (K082757)Bioplate, Inc.2008-10-01
AVANTE Z ZIRCONIA (AS)3 BLOCKS (K081749)Pentron Ceramics, Inc.2008-09-30
OSSTELL ISQ IMPLANT STABILITY METER (K082523)Osstell AB2008-09-26
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX (K082167)Digimed Corporation2008-09-26
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 (K082449)Bisco, Inc.2008-09-25
BISQUE ZIRCONIA BLANKS, TYPE BYZ (K081850)Zircar Zirconia, Inc.2008-09-25
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT (K080164)Zimmer Dental, Inc.2008-09-25
DAMON 4CLEAR (K081415)Ormco Corp.2008-09-24
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER (K081514)Lang Dental Mfg. Co., Inc.2008-09-22
MDI MII ONE-PIECE IMPLANT, 2.9MM (K081653)Imtec Corp.2008-09-19
INFILTRATION KIT (K081493)Dmg USA, Inc.2008-09-18
ZENO AI ECO DISC (K082257)Wieland Dental + Technik GmbH & Co. KG2008-09-18
OSSEOSPEED TM PROFILE SYSTEM (K080156)Astra Tech AB2008-09-17
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL (K081810)Pulpdent Corporation2008-09-17
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN (K081705)Lang Dental Mfg. Co., Inc.2008-09-17
INVENTUS IMPLANT SYSTEM (K081579)Inventus Co., Ltd.2008-09-17
MASTERGRAFT PUTTY (K081784)Medtronic Sofamor Danek2008-09-17
DENJECTOR (K081694)Dxm Co., Ltd.2008-09-12
SIMPACT IMPLANT SYSTEM (K081226)Simpact, LLC2008-09-12
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE (K080682)Handpiece Headquarters, Inc. - Hpr, Inc.2008-09-11
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT (K082560)Kettenbach GmbH & Co. KG2008-09-08
METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER (K081913)Meta Biomed Co., Ltd.2008-09-05
ARDS DENTAL IMPLANTS (K071803)Ards, Ltd.2008-09-05
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER (K081961)Brontes Technologies2008-09-05
CARBOXYLATE CEM, PHOSPHATE CEM (K081702)S & C Polymer GmbH2008-09-05
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K081747)Synthes (Usa)2008-09-05
FORTOSS VITAL (K082383)Biocomposites, Ltd.2008-09-05
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS (K080089)Sybron Dental Specialties, Inc.2008-09-04
MS SYSTEM (NARROW RIDGE) (K080594)Osstem Implant Co., Ltd.2008-09-03
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS (K073478)Sybron Dental Specialties, Inc.2008-09-03
SNAPSHOT (K081925)Instrumentarium Dental, Palodex Group OY2008-09-02
HU/HS/HG PROSTHETIC SYSTEM (K081575)Osstem Implant Co., Ltd.2008-09-02
PERIMETRICS PERIOMETER (K072213)Perimetrics, Inc.2008-08-29
OTA COLLAGEN BIOMATERIAL (K073685)Osseous Technologies of America2008-08-29
PLANMECA SOVEREIGN (K081699)Planmeca USA, Inc.2008-08-29
HEALOS II BONE GRAFT SUBSTITUTE (K081432)Depuy Spine, Inc.2008-08-29
LUTE-IT II VENEER CEMENT, MODEL NO6 (K081887)Pentron Clinical Technologies2008-08-29
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO (K081550)Bonart Co., Ltd.2008-08-28
XIOS PLUS WALL-MODULE (K081903)Sirona Dental Systems GmbH2008-08-26
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT (K081237)Craftmaster Contour Equipment, Inc.2008-08-25
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES (K080761)Bonart Co., Ltd.2008-08-25
WESTAR SERIES DENTAL UNITS (K082294)Westar Medical Products, Inc.2008-08-22
XERACEM (K081405)Doxa Dental AB2008-08-21
ANYRAY PORTABLE X-RAY SYSTEM (K081899)E-Woo Technology Co., Ltd.2008-08-21
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW (K081393)G & H Wire Co.2008-08-21
RESCUE EXTERNAL IMPLANT SYSTEM (K081302)Megagen Implant Co., Ltd.2008-08-15
DMC COMPOSITE (K081695)Kerr Corp.2008-08-12
DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 (K081200)Global Top, Inc.2008-08-08
TCM ENDO 20 (K081191)NOUVAG AG2008-08-07
APROXI 1100 AND 4000 SERIES DENTAL INLAYS (K073047)Aproxi Aps2008-08-07
TRICOS A RESORBABLE SUBSTITUTE (K081721)Baxter Healthcare Corp2008-08-06
KETTOSIL AND SILGINAT (K082157)Kettenbach GmbH & Co. KG2008-08-06
TEMPLATE AND COUNTER-FIT (K081017)Clinician'S Choice Dental Products, Inc.2008-08-04
RADIANCE (K080749)American Orthodontics2008-08-04
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939)W&H Dentalwerk Buermoos GmbH2008-07-29
CLEARFIL SA CEMENT (K081583)Kuraray Medical, Inc.2008-07-28
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE (K080220)Italia Medica S.R.L.2008-07-28
OSFERION D (K081561)Olympus Terumo Biomaterials Corporation2008-07-28
VOCO PROFLUORID VARNISH (K080814)Voco GmbH2008-07-24
ACCUFRAME (K081157)Cagenix, Inc.2008-07-22
SONICWELD RX (RESORB-X) (K080862)KLS-Martin L.P.2008-07-21
CAM STRUCTSURE PRECISION MILLED BARS (K080864)Biomet 3i, Inc.2008-07-21
PROGENIX PLUS (K081950)Medtronic Sofamor Danek, Inc.2008-07-18
HG II FIXTURE SYSTEM (K080744)Osstem Implant Co., Ltd.2008-07-17
LION SE ONE STEP ORTHODONTIC ADHESIVE (K080445)Classone Orthodontics, Inc.2008-07-16
SCREWINDIRECT DENTAL IMPLANTS (K080633)Implant Direct, LLC2008-07-15
NT/IT SYSTEM (K081078)Osstem Implant Co., Ltd.2008-07-15
VARIOSURG (K073678)Nakanishi, Inc.2008-07-10
ULTRACAPS S (K081273)Sdi , Ltd.2008-07-10
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK (K080224)SOADCO, S.L.2008-07-03
STARCERAM (K081263)H.C. Starck Ceramics GmbH & Co.Kg2008-07-01
NOMAD PRO X-RAY SYSTEM (K081664)Aribex, Inc.2008-06-23
SMARTBURS (K080687)S.S. White Burs, Inc.2008-06-20
ESTELITE SIGMA QUICK (K080940)Tokuyama Dental Corporation2008-06-19
ENDSNOR (K072731)Dockstader Orthodontic Lab, Inc.2008-06-12
GC OPB-100 (K080724)GC America, Inc.2008-06-11
RESICEM (K080517)Shofu Dental Corp.2008-06-11
VINTAGE ART (K080834)Shofu Dental Corp.2008-06-11
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