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Dental

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

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RecordFirmDate
LORENZ ORTHODONTIC ANCHORAGE SYSTEM (K063386)Walter Lorenz Surgical, Inc.2007-02-09
MICROLUX TRANSILLUMINATOR (K062961)Addent, Inc.2007-02-08
DURAFLEX (K063626)Cosmetic Dental Materials, Inc.2007-02-08
KAVO EVEREST C-TEMP (K063624)Kavo America2007-02-08
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM (K070219)Suni Medical Imaging, Inc.2007-02-07
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (K063856)Essential Dental Systems, Inc.2007-02-06
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT (K070297)Dental Air Solutions of Nc, Inc.2007-02-05
CERAMILL ZI (K063511)Amann Girrbach America, Inc.2007-02-02
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE (K070001)Mti Precision Products2007-02-02
CLEARFIL MAJESTY FLOW (K063593)Kuraray America, Inc.2007-02-02
AXCEL FLOW (K063714)Tri Dental Innovators2007-01-31
CARRARA VOLUMIA (K070019)Dentsply Intl.2007-01-26
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT (K070196)Hr Dental Products, Inc.2007-01-26
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC (K070155)Osseo Scientific, LLC2007-01-25
TWINKY STAR NF (K063604)Voco GmbH2007-01-22
ACE BOND SE (K063780)Bisco, Inc.2007-01-19
LINGLOCK (K061042)Sybron Dental Specialties2007-01-19
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (K063052)Walter Lorenz Surgical, Inc.2007-01-12
MERON PLUS (K063554)Voco GmbH2007-01-12
TENDER FIBER (K063170)Micerium S.P.A.2007-01-12
PORTABLE X-RAY SYSTEM, MODEL PORT-X II (K063121)Genoray Co., Ltd.2007-01-11
SPI ELEMENT PLATFORM O 4.0 MM (K070007)Thommen Medical AG2007-01-10
RELIEF ACP ORAL CARE GEL (K062176)Discus Dental, Inc.2007-01-10
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K063181)Synthes (Usa)2007-01-05
SFB AND CFB IMPLANTS - 5.0 PLATFORM (K063718)Nobel Biocare AB2007-01-05
PENCURE, MODEL VL-7 (K063529)J. Morita USA, Inc.2007-01-05
BONART ART-L3 LED CURING LIGHT (K062289)Bonart Co., Ltd.2007-01-03
ENA CEM (K062355)Micerium S.P.A.2006-12-27
CRANEX NOVUS (K063459)Soredex Palodex Group OY2006-12-26
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE (K062277)Atlantis Components, Inc.2006-12-20
NOBELPERFECT CONICAL CONNECTION (K062936)Nobel Biocare AB2006-12-19
SOMNOFIT (K060795)Strategic Counsel Sarl2006-12-18
CERAMIC BOND (K062345)Voco GmbH2006-12-15
OSSPRAY CLEANING COMPOUND (K062502)Ospray, Ltd.2006-12-15
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES (K062947)Peng Lim Enterprise Co., Ltd.2006-12-14
LAIMAD (K062333)Steven Lamberg, D.D.S2006-12-14
C-U2 (K062897)Cefla S.C.R.L.2006-12-14
PEAK SE, MODEL 5135 (K063558)Ultradent Products, Inc.2006-12-14
TF ROTARY NICKEL TITANIUM FILE (K062856)Ormco Corp.2006-12-13
PEAK BOND, MODEL 5133 (K063557)Ultradent Products, Inc.2006-12-12
TAP III ANTI-SNORING DEVICE (K062951)Airway Management, Inc.2006-12-12
USI DENTAL SCALER, 25XXX SERIES (K062791)Ultrasonic Services, Inc.2006-12-11
SURFACE COAT (K063228)Kuraray America, Inc.2006-12-08
MINISCREWS ANCHORING SYSTEM, M.A.S. (K062367)Micerium S.P.A.2006-12-08
THERACAL LC (K063237)Bisco, Inc.2006-12-08
NOBELREPLACE TAPERED CONICAL CONNECTION (K062566)Nobel Biocare USA, LLC2006-12-06
DEMETRON A.2 (K063116)Sybron Dental Specialties2006-12-05
CELERITY (K062518)Parkell, Inc.2006-12-04
HKBOND 2006 (K063062)Heraeus Kulzer, Inc.2006-12-01
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM (K062749)Nobel Biocare AB2006-11-29
REGEN BIOCEMENT (K063010)Steiner Laboratories2006-11-28
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N (K062812)Thunder Tiger Corp.2006-11-28
AURORA (K063003)Parkell, Inc.2006-11-28
RETENTION FLOW OPAQUE (K062515)Heraeus Kulzer,GmbH2006-11-22
BIOHORIZONS CERAMIC ABUTMENT (K061567)BioHorizons Implant Systems, Inc.2006-11-22
BIOAGGREGATE (K063422)Innovative Bioceramix, Inc.2006-11-21
ENAMEL PRO VARNISH (K062683)Premier Dental Products Co.2006-11-21
THE 5.0 X 6.0MM DENTAL IMPLANT (K062044)Bicon, Inc.2006-11-21
ENAMEL PRO (K062166)Premier Dental Products Co.2006-11-21
LAVA SOFTWARE (K062493)3M Espe AG Dental Products2006-11-17
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED (K062851)Osteomed LP2006-11-17
ENA HFO COMPOSITE SYSTEM (K062906)Micerium S.P.A.2006-11-17
IMPRESSIX, COLORCHANGE ALGINATE (K062400)Cavex Holland BV2006-11-16
RIVA LUTING PLUS (K062065)Southern Dental Industries, Inc.2006-11-15
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES (K063302)Shanghai Dental Instrument Factory2006-11-15
IMAX CEPH DIGITAL X-RAY SENSOR (K062403)Owandy2006-11-14
RIVA BOND LC (K062064)Southern Dental Industries, Inc.2006-11-09
TOMAS PIN SD 6, 8, AND 10 MM (K062733)Dentaurum2006-11-09
K-ETCHANT GEL (K062409)Kuraray Medical, Inc.2006-11-08
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 (K062886)CAO Group, Inc.2006-11-06
GRANDIO FLOW TRY-IN (K062343)Voco GmbH2006-11-02
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU (K062740)Jindell Medical Instruments Co., Ltd.2006-11-02
US SYSTEM (K062030)Osstem Implant Co., Ltd.2006-11-02
ADHESIVE DC ACTIVATOR (K062713)Ivoclar Vivadent, Inc.2006-11-02
SS SYSTEM (K062051)Osstem Implant Co., Ltd.2006-11-01
PRIMACONNEX CERAMIC ABUTMENTS (K062876)Lifecore Biomedical, Inc.2006-11-01
TUTU 7, MODEL IV-T22 (K062735)Invisible Technology Co., Ltd.2006-10-27
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE (K060889)Pentron Clinical Technologies2006-10-27
CST61 HIGH SPEED TURBINE HANDPIECE (K063110)Shanghai Dental Instrument Factory2006-10-26
UNICEM (K062292)3M Espe Dental Products2006-10-25
TOMAS PIN 6 MM (K062732)Dentaurum2006-10-25
P.0004 IMPLANTS (K062129)Institut Straumann AG2006-10-20
SUPER ORTHODONTIC SCREW (K062156)Osstem Implant Co., Ltd.2006-10-20
SAGEMAX Z-BLANK (K062695)Sagemax Bioceramics, Inc.2006-10-20
K-SPRAY, MODEL 085-2715 (K062418)Scican2006-10-19
NEXUS 3 (K062519)Kerr Corporation2006-10-19
CLARITY MODIFIED CERAMIC BRACKETS (K062305)3M Unitek2006-10-18
DENSHIELD TREATMENT FOR SENSITIVE TEETH (K061359)Novamin Technology, Inc.2006-10-18
POWERTOME PERIOTOME (K063007)Westport Medical, Inc.2006-10-17
CONFORM (K062157)Apex Dental Materials, Inc.2006-10-13
COLLAGEN DENTAL MEMBRANE III (K062846)Collagen Matrix, Inc.2006-10-13
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S (K061847)Zimmer Dental, Inc.2006-10-12
COLLAGEN DENTAL MENBRANE - CONFORMABLE II (K062881)Collagen Matrix, Inc.2006-10-11
ZERION ALPHA, ; ZERION BETA (K061804)Etkon International GmbH2006-10-06
BELMAX CM MODEL X168 (K062529)Takara Belmont USA, Inc.2006-10-05
PREMIER SELF-ETCHING BOND ENHANCER (K061998)Premier Dental Products Co.2006-10-04
PREMIER SELF-ETCHING ENAMEL SEALANT (K061997)Premier Dental Products Co.2006-10-04
GRANDIO SEAL (K062344)Voco GmbH2006-10-02
ZIRKONZAHN ICE (K061851)Zirkonzahn GmbH2006-09-29
SPECTRA SYSTEM (K061319)Implant Direct, LLC2006-09-29
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