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Dental

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

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RecordFirmDate
CAM STRUCTSURE BARS (K101582)Biomet 3i, Inc.2010-11-08
GRANDIO SO (K102351)Voco GmbH2010-11-02
ALL-BOUND 3 (K102844)Bisco, Inc.2010-10-29
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE (K101540)Novocol Inc. Dba Septodont and Confi-Dental Produc2010-10-29
TI-CORE FLOW (K101504)Essential Dental Systems, Inc.2010-10-29
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) (K102575)Do Co., Ltd.2010-10-29
GRANDTEC (K102347)Voco GmbH2010-10-29
GENESIS IMPLANT SYSTEM (K101545)Keystone Dental2010-10-28
ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI (K102538)Jyoti Ceramic Industries Private Limited2010-10-27
ECO-S (K103121)Vericom Co., Ltd.2010-10-26
LIGHT CURE RETAINER (K101951)Reliance Orthodontic Products, Inc.2010-10-26
OSSEOCONDUCT (K101718)Steiner Laboratories Div of Steiner Healthcare, LLC2010-10-26
SIRONA CAD/CAM SYSTEM (K100152)Sirona Dental Systems GmbH2010-10-22
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S (K100248)Drfp , Ltd.2010-10-22
BLO2X OXYGEN BLOCKER (K102526)Pascal Co., Inc.2010-10-22
DENTACENTER/EXPEDITION, MODEL SAF-430 (K100212)Safari Dental, Inc.2010-10-22
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102124)VATECH Co., Ltd.2010-10-22
REMIN PRO (K101104)Voco GmbH2010-10-21
TOKUYAMA SHIELD FORCE (K100172)Tokuyama Dental Corporation2010-10-21
BOND BONE (K101014)Mis Implants Technologies , Ltd.2010-10-21
WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS (K100960)Cefla Dental Group2010-10-21
VISTEO (K093105)Owandy2010-10-18
REALSEAL XT SEALER (K102163)Kerr Corporation2010-10-16
ENDOSSEOUS DENTAL IMPLANT (K093562)Southern Implants, Inc.2010-10-14
IONOLUX PRO (K102450)Voco GmbH2010-10-08
DUOLINK II (K101787)Bisco, Inc.2010-10-08
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD (K100653)Lang Dental Mfg. Co., Inc.2010-10-08
HT III SA FIXTURE SYSTEM (K101096)Hiossen, Inc.2010-10-08
ORTHOPANTOMOGRAPH OP300 (K093683)Instrumentarium Dental, Palodex Group OY2010-10-06
TDS PRECISION DENTAL BAR (K100356)Pou YU Biotechnology Co., Ltd.2010-10-05
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT (K101849)Bicon, LLC2010-10-01
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT (K101880)Zimmer Dental, Inc.2010-10-01
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) (K101869)Silmet , Ltd.2010-09-29
LUXATEMP ULTRA /STAR (K101710)Dmg USA, Inc.2010-09-28
VITOMATRIX (K091618)Orthovita, Inc.2010-09-27
DIRECT CROWN NATURAL 1 (K101814)Candulor USA, Inc.2010-09-27
ASCENT F-COAT MODEL: 006-00097 (K100540)CAO Group, Inc.2010-09-23
RELINE-IT MODEL RELINE-IT (K101771)Majestic Drug Co., Inc.2010-09-20
GC FUJI TEMP (K101420)GC America, Inc.2010-09-17
ULTRASEAL ID (K101245)Ultradent Products, Inc.2010-09-17
MYRAY HYPERION (K101661)Cefla Dental Group2010-09-16
CEROS TCP GRANULES (K101426)Mathys, Ltd.2010-09-15
TAPERED SCREW-VENT T IMPLANT (K101977)Zimmer Dental, Inc.2010-09-14
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (K101064)Bredent GmbH & Co. KG2010-09-14
CLEARARCH (K101676)Ormco Corp.2010-09-13
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK (K100985)BioHorizons Implant Systems, Inc.2010-09-09
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M (K101551)Delma Medical Instrument (Guangzhou) Co., Ltd.2010-09-09
EMS MINIMASTER LED (K093723)E.M.S Electro Medical Systems S.A2010-09-08
SNORE GUARD ADVANCE (K102118)Ranir, LLC2010-09-08
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL (K101617)Heraeus Kulzer, LLC2010-09-07
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS (K101714)Nobel Biocare AB2010-08-31
FS ALIGNER (K093821)Allesee Orthodontic Appliances2010-08-27
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E (K101485)Bisco, Inc.2010-08-26
STAR/VENT INTERNAL HEX SCREW IMPLANT (K082800)Park Dental Research Corp.2010-08-26
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS (K101068)Radiant Express, LLC2010-08-23
BEAUTIFIL FLOW PLUS (K101603)Shofu Dental Corp.2010-08-23
LITE ART (K101621)Shofu Dental Corp.2010-08-23
BK BLANK MODEL 20,40,65,90 (K101875)Bk Medent Co., Ltd.2010-08-23
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING (K101717)Aerobine, Inc.2010-08-20
NOBELPROCERA IPS E.MAX CROWN (K100512)Nobel Biocare AB2010-08-20
GRANDIO FLOW (K101213)Voco GmbH2010-08-19
SPI VARIOMULTI ANGLED ABUTMENT (K101798)Thommen Medical AG2010-08-19
ADVANCED GLASS IONOMER (K-130) RESTORATIVE (K101493)Dentsply International, Inc.2010-08-19
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) (K101709)Steven B. Lamberg, Dds2010-08-18
OSTA MAXIGRO AND REGIGRO (K091424)Osta Technologies2010-08-18
HS/HG PROSTHETIC SYSTEM (K100245)Osstem Implant Co., Ltd.2010-08-17
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT (K101004)Astra Tech, Inc.2010-08-16
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH (K101029)Huge Dental Material Co., Ltd.2010-08-16
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT (K100389)Handpiece Headquarters2010-08-12
VITABLOCS (K102128)Vita Zahnfabrik H.Rauter GmbH & Co.2010-08-11
COLLAGEN DENTAL MEMBRANE V (K100156)Collagen Matrix, Inc.2010-08-11
NEODENT IMPLANT SYSTEM (K101207)Jjgc Industria E Comercio DE Materiais Dentarios S2010-08-02
EMS PIEZON MASTER 700 (K093000)E.M.S Electro Medical Systems S.A2010-07-30
OPTIBOND XTR (K101423)Kerr Corporation2010-07-30
VARIOUS DENTAL IMPLANTS (K100411)Grundy Advanced Biomedical Systems, LLC2010-07-28
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE (K100536)3M Unitek2010-07-27
RDT3 HANDPIECE HEAD MODEL RDT3 (K101172)Redent Nova, Ltd.2010-07-27
MAM COOLER (K093266)Mam International AG2010-07-27
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM (K092261)Impladent, S.L.2010-07-23
DETAX IMPLANTLINK SEMI (K100247)Detax GmbH & Co. KG2010-07-23
SARGON NON-EXPANDABLE DENTAL IMPLANT (K082573)Sargon Ent., Inc.2010-07-21
SOPIX 2 (K092329)Sopro2010-07-20
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) (K100752)Ultradent Products, Inc.2010-07-16
DENTLIGHT ORAL EXAM LIGHT KIT (K101140)Dentlight, Inc.2010-07-15
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM (K100647)A-Dec, Inc.2010-07-09
COTEC DENTAL IMPLANT SYSTEM (K100511)Cotec Implant Co., Ltd.2010-07-09
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 (K100600)W&H Dentalwerk Buermoos GmbH2010-07-09
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM (K101060)Siesta Medical, Inc.2010-07-08
BONE PLUS BCP (K090950)Megagen Implant Co., Ltd.2010-07-02
ZEN CORDLESS PROPHY SYSTEM (K101612)Discus Dental, LLC2010-06-30
MEDPOR FIXATION SYSTEM (K091807)Porex Surgical, Inc.2010-06-28
STERN'S S250 NORDAM (K092917)Cefla S.C.2010-06-24
AEDIS(TM) (K100902)Embed Technology, LLC2010-06-24
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS (K093643)Nobel Biocare AB2010-06-24
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET (K101481)Biomers Products, LLC2010-06-23
MAM TWISTER (K092781)Mam International AG2010-06-23
TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS (K090081)Talladium Espana, SL2010-06-22
ZQUIET MOUTHPIECE (K093407)Sleeping Well, LLC2010-06-22
UNICEM HM (K100908)3M Espe AG Dental Products2010-06-22
OBSIDIAN CERAMIC BLOCKS (K100781)Prismatik Dentalcraft, Inc.2010-06-21
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