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Dental

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

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RecordFirmDate
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM (K073282)BioHorizons Implant Systems, Inc.2008-02-15
3M ESPE ADULT CROWN (K072733)3M Company2008-02-15
SPI VARIOMULTI ABUTMENT (K072856)Thommen Medical AG2008-02-15
TRANSBOND SUPREME ADHESIVE (K073697)3M Unitek2008-02-15
PENTABORN (K072447)Mediscitec, Inc.2008-02-15
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT (K073258)Atlantis Components, Inc.2008-02-14
PERIOSCAN, MODEL: D 3496 (K072107)Sirona Dental Systems GmbH2008-02-14
GC AADVA ABUTMENT (K072100)GC America, Inc.2008-02-14
PRO-V (K073263)Bisco, Inc.2008-02-14
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX (K080074)Ace Surgical Supply Co., Inc.2008-02-14
ANKYLOS TEMPORARY ABUTMENT BALANCE (K073073)Dentsply International, Inc.2008-02-12
KODAK 9000, KODAK 9000 3D (K073435)Trophy2008-02-11
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 (K080249)Ultradent Products, Inc.2008-02-08
PROVENT NASAL DILATOR, MODEL BR2 (K071560)Ventus Medical, Inc.2008-02-08
LED PRO SEAL (K073243)Reliance Orthodontic Products, Inc.2008-02-08
BIOHORIZONS INTERNAL IMPLANT SYSTEM (K073268)BioHorizons Implant Systems, Inc.2008-02-08
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE (K080240)Promident, LLC2008-02-07
PSL BIOZIR BLOCK (K073568)P.S.L. International, Inc.2008-02-06
WELL-PEX (K080266)Vericom Co., Ltd.2008-02-06
DENFIL ETCHANT-37 (K080265)Vericom Co., Ltd.2008-02-06
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224)Procter & Gamble2008-02-06
ATLAS IMPLANT SYSTEM (K071148)Cowellmedi Co., Ltd.2008-02-06
STATMATIC 31 HANDPIECE MAINTENANCE UNIT (K073319)Scican , Ltd.2008-02-04
MS SYSTEM (DENTURE) (K072959)Osstem Implant Co., Ltd.2008-02-04
NEUN (K073554)Heraeus Kulzer,GmbH2008-02-04
PROVISA CEM (K073539)Cavex Holland BV2008-01-31
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX (K072363)Biomet 3i, Inc.2008-01-31
SOMNOMED BFLEX (K073004)Somnomed, Inc.2008-01-30
MAXCEM 2 (K073209)Kerr Corporation2008-01-29
AXIS SYSTEM (K072989)Dentsply Intl., Inc.2008-01-28
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE (K072754)Axenic Dental, Inc.2008-01-25
ORTHO ANCHOR SCREWS (K073461)Mis Implants Technologies , Ltd.2008-01-25
IMPLASA-HOECHST GMBH IMPLANTS (K071240)Implasa-Hoechst GmbH2008-01-24
SELF-ADHESIVE RESIN CEMENT (K073173)Dentsply Interntional2008-01-23
SYNOCTA ABUTMENTS (K073628)Straumann USA2008-01-22
AURAVENEER CEMENT (K073101)Denali Corporation2008-01-17
TENDER ORTHO BOND-ENA BOND-ENA ETCH (K072978)Micerium S.P.A.2008-01-17
GILB-2, GLASS IONOMER PROTECTIVE COATING (K073395)3M Espe Dental Products2008-01-17
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM (K072917)Odontit S.A.2008-01-14
NOBELREPLACE HEXAGONAL IMPLANT (K073142)Nobel Biocare USA, LLC2008-01-11
MS SYSTEM (PROVISIONAL) (K072871)Osstem Implant Co., Ltd.2008-01-10
TEMPXN28 (K073296)3M Espe AG Dental Products2008-01-09
MTA ADVANCED MATERIAL (K073218)Dentsply Interntional2008-01-07
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM (K070857)Nobel Biocare AB2007-12-28
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES (K072528)Prosurg, Inc.2007-12-28
NOBELACTIVE MULTI UNIT ABUTMENT (K072570)Nobel Biocare AB2007-12-28
3M ESPE LAVA CHAIRSIDE ORAL SCANNER (K073199)Brontes Technologies2007-12-21
FLASHLITE REBEL* (K073518)Discus Dental, Inc.2007-12-20
KLS MARTIN XTERNAL FIXATOR (K072764)KLS Martin L.P.2007-12-20
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS (K072980)Nobel Biocare AB2007-12-20
BELMONT QUOLIS 5000 SERIES DENTAL UNIT (K072273)Takara Belmont USA, Inc.2007-12-20
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642)Biomet 3i, Inc.2007-12-20
DENTIN DESENSITIZER AGENT (K073117)Dentsply Intl., Inc.2007-12-19
SCANORA 3D (K073350)Soredex Palodex Group OY2007-12-19
EMS PIEZON MASTER SURGERY (K072146)E.M.S Electro Medical Systems S.A2007-12-18
SAPPHIRE CERAMIC BRACKET (K073045)Ortho Technology, Inc.2007-12-18
SET PP (K073043)Sdi , Ltd.2007-12-14
AIR-FLOW MASTER STANDARD (K073284)(Ems Sa) Electro Medical Systems2007-12-14
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (K071353)Shanghai Foshion Medical Instruments Co., Ltd.2007-12-14
SCREWPLUS DENTAL IMPLANTS (HA) (K073049)Implant Direct, LLC2007-12-13
SMH FLEX S (K073040)Smh Biomaterial AG2007-12-13
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (K072660)Imtec Corp.2007-12-12
ELITE GLASS (K073005)Zhermack S.P.A.2007-12-12
LEGACY DENTAL IMPLANTS (K073033)Implant Direct, LLC2007-12-10
DO-ALL DENTAL HANDPIECE LUBRICANT (K073353)Prodrive Systems, Inc.2007-12-07
SPI SYSTEM DENTAL IMPLANTS (K072649)Thommen Medical AG2007-12-06
BISICO IMPRESSION SILICONES & ALGINATES (K072577)Bisico GmbH & CO KG2007-12-05
SPI ART ABUTMENT (K073141)Thommen Medical AG2007-12-05
E-1 ESTHETIC COMPOSITE SYSTEM (K072746)Tokuyama Dental Corporation2007-12-04
RM BOND, MODEL J032 (K072830)Pentron Clinical Technologies2007-12-04
STANDOUT 2 (K072622)Kerr Corp.2007-12-04
MODIFICATION TO: LOCATOR IMPLANT ANCHOR (K072878)Zest Anchors, Inc.2007-12-03
SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM (K072463)Satyrne Medical2007-11-29
IMPLUS IMPLANT SYSTEM (K062931)Leader Italia S.R.L.2007-11-28
GENERATION 8 SE ADHESIVE (K072480)Pentron Clinical Technologies2007-11-21
I LIGHT (K072807)Dent'N CO2007-11-21
ZENO ZR DISC (K073108)Wieland Dental + Technik GmbH & Co. KG2007-11-21
IMPLANTIUM PROSTHETICS (K070228)Dentium Co., Ltd.2007-11-20
MICROLUX/BLU (K072309)Addent, Inc.2007-11-19
IMPLANT CENTER (K072030)Satelec - Acteon Group2007-11-19
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (K073032)Lifecore Biomedical, Inc.2007-11-16
DUO TEMP (K072604)Coltene/Whaledent AG2007-11-16
CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US (K072643)Olympus Corporation2007-11-16
ENDOSSEOUS DENTAL IMPLANT SYSTEM (K071161)Southern Implants, Inc.2007-11-16
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS (K072483)Atlantis Components, Inc.2007-11-16
SPI CONTACT PLATFORM O 4.0 MM (K072933)Thommen Medical AG2007-11-15
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (K072554)Sable Industries, Inc.2007-11-14
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD (K072479)Rapid Injection Systems Corp.2007-11-09
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM (K072241)Lifecore Biomedical, Inc.2007-11-09
T.B.R. ZIRCONNECT (K070935)Sudimplant SA2007-11-09
EMULATE ADVANCED (K072245)Cavex Holland BV2007-11-08
SM INTERNAL./EXTERNAL IMPLANT SYSTEM (K070569)Dio Department Dsi, Inc.2007-11-08
GS FIXTURE SYSTEM (K072896)Osstem Implant Co., Ltd.2007-11-06
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 (K072580)Lang Dental Mfg. Co., Inc.2007-11-05
GUMEASE DENTAL MOUTHPIECE (K072082)Biomedevice , Ltd.2007-11-05
SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (K072134)Schick Technologies, Inc.2007-11-02
METOXIT CAM-BLANKS (K072569)Metoxit AG2007-10-31
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX (K062542)Z-Systems AG2007-10-29
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 (K072545)Pentron Clinical Technologies2007-10-26
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) (K071981)Bonart Co., Ltd.2007-10-26
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