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Dental

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

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RecordFirmDate
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (K100539)Preventive Technologies, Inc.2010-06-17
POLYBONE DENTAL (K092194)Kyung Won Medical Co., Ltd.2010-06-16
PASR/QUIETNITE (K093340)Exact Supplies , Ltd.2010-06-11
RETRIEVE IMPLANT CEMENT (K101044)Parkell, Inc.2010-06-10
SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 (K093975)Pan Global Implant2010-06-04
BIODENTA DENTAL IMPLANT SYSTEM (K093630)Biodenta Swiss AG2010-06-03
SYLE SMARTIP (K100833)Osspray, Ltd.2010-06-03
MALTA (K100756)3M Espe AG Dental Products2010-06-02
VATEA ENDONTIC IRRIGATION SYSTEM (K100606)Redent Nova, Ltd.2010-05-28
CERAMICS2IN1 (K100150)Biodenta Swiss AG2010-05-25
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 (K093390)Depuy Spine, Inc.2010-05-25
LUMINESSE ZR BLANKS (K100232)Talladium, Inc.2010-05-21
PULPDENT COPAL VARNISH WITH FLUORIDE (K100503)Pulpdent Corporation2010-05-12
MINXRAY, MODEL: BPD60 (K091255)Minxray, Inc.2010-05-12
FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE (K100235)3M Company2010-05-12
NUANCE (K101215)Discus Dental, LLC2010-05-12
PLANMECA PROMAX 3D MAX (K093590)Planmeca Oy2010-05-12
THE MOSES APPLIANCE (K093710)Allen J. Moses, Dds, Ltd.2010-05-12
ZIT-Z (K092507)Ziterion2010-05-11
ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160)Sleep Specialists, LLC2010-05-11
SALVIN DENTAL SPECIALTIES FIXATION SCREW (K100182)Salvin Dental Specialties, Inc.2010-05-10
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS (K091812)Frontier Devices, Inc.2010-05-07
OPTIBOND SE (K100347)Kerr Corporation2010-04-30
OPAL BOND FLOW (K100301)Ultradent Products, Inc.2010-04-29
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM (K093478)Trophy2010-04-26
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K092171)Genoray Co., Ltd.2010-04-26
FUORECAM (K093705)Therapeutic Technologies, Inc.2010-04-23
M (K092542)Mediscitec, Inc.2010-04-23
MODIFICATION TO: HG III ULTRA WIDE SYSTEM (K093889)Hiossen, Inc.2010-04-22
PERIOPHIL B-TCP (K093871)Cytophil, Inc.2010-04-22
DENTAL HANDPIECE (K093971)North West Medical Instrument (Group) Co., Ltd.2010-04-22
AMERICAN DENTAL PRODUCTS SE BONDEASY (K093014)American Dental Products, Inc.2010-04-16
AIRWAYEASE MAS (K090436)Orthoplant Dental Lab2010-04-16
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT (K093780)Astra Tech, Inc.2010-04-16
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 (K100145)A&E Bioceramic Co., Ltd.2010-04-13
XCERAM (K100250)Xceramusa2010-04-08
UNICEM (K094007)3M Espe AG Dental Products2010-04-08
CENTURY MODEL 105C (K093341)Sybron Dental Specialties, Inc.2010-04-05
SPRYTIE, MODELS ST001, ST002 AND ST003 (K092530)Russell B. Walther2010-04-02
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM (K093321)BioHorizons Implant Systems, Inc.2010-04-02
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 (K100633)D B Orthodontics, Ltd.2010-04-01
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (K100401)Hu-Friedy Mfg. Co., Inc.2010-03-30
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K100671)Novabone Products, LLC2010-03-30
INFILTRATION KIT (K100062)Dmg USA, Inc.2010-03-26
CERAMIR CROWN & BRIDGE (K100510)Doxa AB2010-03-25
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO (K100317)VATECH Co., Ltd.2010-03-24
OPAL BOND MV (K094006)Ultradent Products, Inc.2010-03-23
BELRAY II (K093240)Takara Belmont Corp.2010-03-22
MEDPOR CONTAIN IMPLANT (K091120)Porex Surgical, Inc.2010-03-19
ESTHETICA (K100083)Kerr Corporation2010-03-19
BIO-OSS COLLAGEN (K092428)Ed. Geistlich Soehne AG Fuer Chemische Industrie2010-03-18
MBCP+ (K093122)Biomatlante2010-03-15
ZR DENTAL BLOCK (K093571)Ams Co., Ltd.2010-03-12
EXCITE F AND EXCITE DSC (K093744)Ivoclar Vivadent, Inc.2010-03-10
TELIO CAD (K093708)Ivoclar Vivadent, Inc.2010-03-10
PULPDENT FLUORIDE VARNISH (K093620)Pulpdent Corporation2010-03-10
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH (K092141)3M Espe Dental Products2010-03-10
CLEARFIL MAJETY POSTERIOR (K100328)Kuraray Medical, Inc.2010-03-05
MIZZY EXPRESS (K093380)Mycone Dental Supply Co., Inc.2010-03-05
GLUMA DESENSITIZER POWER GEL (K093575)Heraeus Kulzer, LLC2010-03-05
SPI DENTAL IMPLANT, ELEMENT (K093615)Thommen Medical AG2010-03-04
VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS (K092857)Whip-Mix Corp.2010-03-04
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (K093894)Anthogyr2010-03-03
VINTAGE MP (K093559)Shofu Dental Corp.2010-03-03
GS III SYSTEM (K091208)Osstem Implant Co., Ltd.2010-03-03
TEMP IT (K100413)Spident Co., Ltd.2010-03-03
GEL FILLED GUM SOOTHER (K092494)Luv N' Care, Ltd.2010-03-01
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# (K093719)Osteogenics Biomedical, Inc.2010-03-01
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT (K083876)Cendres & Metaux SA2010-02-26
DD BIO Z AND DD BIO Z - TRANSPA (K093748)Dental Direkt of Amerika UG (Haftungsbeschraenkt)2010-02-24
CL-DC20, CL-DC21 (K093751)Good Doctors Co., Ltd.2010-02-24
HG II SHORT FIXTURE SYSTEM (K091678)Osstem Implant Co., Ltd.2010-02-18
CORE-FLO D/C (K093470)Bisco, Inc.2010-02-17
ESTEMP NE (K100290)Spident Co., Ltd.2010-02-17
SELF ADHESIVE COMPOSITE LUTING CEMENT (K093338)Dmg USA, Inc.2010-02-12
SIMPLISEAL (K093208)Discus Dental, LLC2010-02-12
STRAUMANN RC TEMPORARY ABUTMENTS (K093027)Straumann USA2010-02-12
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT (K093059)Classone Orthodontics, Inc.2010-02-04
STRONG DENTAL HANDPIECES (K100192)Saeshin Precision Co., Ltd.2010-02-04
SR PHONARES NHC (K093331)Ivoclar Vivadent, Inc.2010-01-28
UPCERA ZIRCONIA BLANKS (K093560)Shenyang Upcera Co., Ltd.2010-01-28
TAKE 1 ADVANCED RIGID TRAY (K092176)Kerr Corporation2010-01-28
PREMISE FLOWABLE MODIFIED (K093484)Kerr Corporation2010-01-27
RAPIDSORB PLUS SCREW SYSTEM (K093464)Synthes (Usa)2010-01-25
BTI DENTAL IMPLANT 5.5-6.5 (K091387)B.T.I. Biotechnology Institute, Sl.2010-01-22
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (K093370)Fu Hong Industries , Ltd.2010-01-21
DENTAL MERCURY (K093587)Dmg USA, Inc.2010-01-21
THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K092743)Stryker Craniomaxillofacial2010-01-15
SAF (SELF ADJUSTING FILE) (K092933)Redent-Nova , Ltd.2010-01-14
W&H HANDPIECE ANESTO, MODEL: RA-5 (K083811)W&H Dentalwerk Buermoos GmbH2010-01-14
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM (K093518)Ace Surgical Supply Co., Inc.2010-01-14
SOPROLIFE (K092583)Sopro2010-01-13
VITAL SLEEP (K092942)The Snore Reliever Company, LLC2010-01-13
ENDOMAX CORDLESS ENDODONTIC HANDPIECE (K092833)Dentamerica2010-01-07
CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 (K091182)Champions Implants GmbH2010-01-07
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY (K092772)Hanjin Digi-X Co., Ltd.2010-01-06
UNO NARROW IMPLANT (K092555)Mis Implants Technologies , Ltd.2010-01-05
MORPHEUS (K082249)Meibach Tech Ltda2009-12-31
MEDTRONIC DENTAL TCP (K092087)Medtronic Sofamor Danek USA, Inc.2009-12-30
MILTEX MEMBRANE TACK KIT (K092855)Miltex, Inc.2009-12-29
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