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Dental

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

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RecordFirmDate
ZIRCONIA BLANKS (ZIRCOSTAR) (K120852)Kerox, Ltd.2012-06-06
PROSOFT (K121318)Perma Laboratories2012-06-06
MILLENIUM ANTI-SNORING DEVICE (K112627)Millenium Dental Laboratory, Inc.2012-06-06
LOCATOR OVERDENTURE IMPLANT SYSTEM (K120198)Zest Anchors, LLC2012-06-06
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (K121131)Straumann USA2012-06-06
MACH BRACKETS BRIGHT BRACKETS (K120471)World Bio Tech Co., Ltd.2012-06-04
SNORKEL (K112766)Fellmar Company2012-06-04
STRUCTUR 3 (K120779)Voco GmbH2012-06-01
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... (K111798)Sterngold Dental, LLC2012-06-01
CLEAN AND BOOST (K120620)Apex Dental Materials, Inc.2012-05-31
SOMNODENT G2 (K121340)Somnomed, Inc.2012-05-30
ARTISAN SPACE MAINTENANCE SYSTEM (K120271)Medtronic Sofamor Danek USA, Inc.2012-05-30
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM (K112585)Adin Dental Implants System, Ltd.2012-05-24
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O (K120601)Geistlich Pharma AG2012-05-24
ES BOND (K120767)Spident Co., Ltd.2012-05-24
TEMPSPAN CLEAR MATRIX (K120013)Pentron Clinical2012-05-22
ORTHODONTIC FLOWABLE BRACKET ADHESIVE (K120619)Novocol, Inc.2012-05-21
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (K120404)Merz Dental GmbH2012-05-21
LEFORTE SYSTEM BONE PLATE & SCREW (K112457)Arkin Consulting Group2012-05-18
SR PHONARES II (K120736)Ivoclar Vivadent, AG2012-05-14
GC BLUE SILICONE (K120521)GC America, Inc.2012-05-10
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM (K120106)Apixia, Inc.2012-05-07
QUANTUM DENTAL IMPLANT SYSTEM (K112279)Quantum Bioengineering, Ltd.2012-05-04
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (K112665)J. Morita USA, Inc.2012-05-04
ES FLOW (K120768)Spident Co., Ltd.2012-05-03
FLASH (DIFFERENT MATERIALS) (K120438)3M Deutschland GmbH2012-05-02
CSM INTERNAL-R IMPLANT SYSTEM (K120043)Csm Implant2012-04-27
PALTOP DENTAL IMPLANT SYSTEM (K112795)Paltop Advanced Dental Solutions, Ltd.2012-04-20
BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037)Beavers Dental, Div. Sybron Canada, Ltd.2012-04-20
AB DENTAL DEVICES IMPLANTS AND ACCESSORIES (K112440)A.B. Dental Devices , Ltd.2012-04-18
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES (K112305)Thunder Tiger Corp.2012-04-17
DEFLEX (K113608)Nuxen S.R.L.2012-04-10
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT (K113674)Handpiece Headquarters, Inc. - Hpr, Inc.2012-04-05
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE (K110481)Asi Medical, Inc.2012-04-05
CMI IMPLANT IS SYSTEM (K113554)Neobiotech Co., Ltd.2012-04-05
NUCAL (K120003)Pulpdent Corporation2012-04-05
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120379)Kuraray Medical, Inc.2012-03-30
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA (K113431)Bettini S.P.A.2012-03-30
ETCH-RITE SUPREME (K120213)Pulpdent Corporation2012-03-30
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120378)Kuraray Medical, Inc.2012-03-30
ATTUNE SLEEP APNEA SYSTEM (K111549)Apnicure, Inc.2012-03-30
RESIGLASS PASTE (K112307)Shofu Dental Corporation2012-03-28
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K113672)VATECH Co., Ltd.2012-03-27
ANESTHESIA INJECTION TOOL SET (K113247)Ki Works Co., Ltd.2012-03-27
RESORB X-G (K112064)KLS-Martin L.P.2012-03-23
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP (K103704)Zephyr Sleep Technologies, Inc.2012-03-23
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (K113818)Pulpdent Corporation2012-03-21
CLEARCORRECT SYSTEM (K113618)Clearcorrect, Inc.2012-03-19
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) (K112078)Maruchi2012-03-19
FILTEK BULK FILL FLOWABLE RESTORATIVE (K120453)3M Espe Dental Products2012-03-19
UNIVERSAL MAXILLARY MOLAR (K110337)Oco Biomedical2012-03-16
DEFLEX ACRILATO (K113788)Nuxen S.R.L.2012-03-16
ENDO-EXPRESS (R) HANDPIECE (K111541)Essential Dental Systems, Inc.2012-03-16
HILLA DIGITAL TRANSFERS (K113575)Hilla Technologies, Inc.2012-03-07
SUPER SEAL TOOTH DESENSITIZER (K120109)Phoenix Dental, Inc.2012-03-07
VIVI ERGON-X HF (K120318)Vivi S.R.L.2012-03-06
LIME-LITE II (K113711)Pulpdent Corporation2012-03-05
TI-MAX X TURBINE (K113655)Nakanishi, Inc.2012-03-05
SPEE-DEE PATCH (K113617)Pulpdent Corporation2012-03-02
CS 1600 INTRAORAL CAMERA (K111423)Carestream Health, Inc.2012-03-02
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... (K113003)Astra Tech, Inc.2012-03-01
APNEARX (K113569)Apnea Science Corporation2012-03-01
PROULTRA PIEZO ULTRASONIC (K113430)Satelec - Acteon Group2012-02-23
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE (K113222)Nakamura Dental Handpiece Mfg. Co., Ltd.2012-02-23
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 (K112758)Kat Implants, LLC2012-02-23
SIRONA DENTAL CAD/CAM SYSTEM (K111421)Sirona Dental Systems GmbH2012-02-17
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT (K111935)Nt-Trading GmbH and CO KG2012-02-17
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 (K110278)Nakanishi, Inc.2012-02-15
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL (K113406)Dentsply International, Inc.2012-02-13
PILLAR PALATAL IMPLANT SYSTEM (K110623)Medtronic Xomed, Inc.2012-02-10
ORTHOSLENDERIZER (K111249)Orthomatics, Inc.2012-02-08
VERACIA SA (K113426)Shofu Dental Corporation2012-02-08
MEDICAL IMAGE PROCESSING UNIT (K113360)Humanray Co,Ltd2012-02-07
PROPHY-MATE NEO (K112673)Nakanishi, Inc.2012-02-07
ORTHO-1(NOT FINALIZED) (K113401)Bisco, Inc.2012-02-07
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS (K113334)Opal Orthodontics by Ultradent Products, Inc.2012-02-03
S-MINI IMPLANT SYSTEM (K112540)Neobiotech Co., Ltd.2012-02-03
PIEZOTOME SOLO (K112188)Satelec - Acteon, Inc.2012-02-03
CONTOUR HEALER (K112099)Contour Healer, LLC2012-02-03
APC FLASH-FREE ADHESIVE (K113197)3M Unitek Corporation2012-02-02
HAPTITE COATING IMPLANT SYSTEM (K111364)Dentis Co., Ltd.2012-02-01
LRT ATTACHMENT (K112333)Bcf Certification, Inc.2012-01-30
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS (K112875)Blue Sky Bio, LLC2012-01-27
NNC GOLD ABUTMENT FOR BRIDGES (K113606)Straumann USA2012-01-27
SOCKET GRAFT (K113049)Steiner Laboratories2012-01-27
SIMPLELINE II ABUTMENT SYSTEM (K112045)Dentium Co., Ltd.2012-01-26
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A (K112044)Anaxdent GmbH2012-01-26
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT (K112574)Prime Dental Manufacturing, Inc.2012-01-23
PCXX VARNISH (K113146)Ross Healthcare, Inc.2012-01-23
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES (K113301)Dentalez, Inc.2012-01-23
ZIMMER CONTOUR PROVISIONAL COPING (K113092)Zimmer Dental, Inc.2012-01-23
REGENEROSS ALLOGRAFT PLUS MINERLIZED (K113645)Biomet Interpore Cross2012-01-20
TORQTECH (K103697)J. Morita USA, Inc.2012-01-20
OSTEON II (K112716)Genoss Co., Ltd.2012-01-17
HYPERION (K113497)Cefla S.C. Cefla Dental Group2012-01-17
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION (K112730)Biomet 3i2012-01-13
HEISENBERG EFFECT SHADES (K120011)3M Espe AG2012-01-13
SLIM ONEBODY SYSTEM (K111162)Dentium Co., Ltd.2012-01-13
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT (K113410)Straumann USA2012-01-13
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM (K112707)Ortho Technology, Inc.2012-01-13
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