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Dental

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

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RecordFirmDate
DMRC Dual Cure Orthodontic Band Cement (K142881)Danville Materials, LLC2015-02-13
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS (K133268)Schutz-Dental GmbH2015-02-12
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color (K142987)Dental Direkt of Amerika UG (Haftungsbeschraenkt)2015-02-11
PMMA BLOCK (K141421)Rizhao Huge Dental Industry Co., Ltd.2015-02-09
SonicFill 2 (K143209)Sybron Dental Specialties2015-02-05
DMRC Light Cure Orthodontic Adhesive System (K142880)Daville Materials, LLC2015-02-04
TCS Blend (K142894)Thermoplastic Comfort Systems, Inc.2015-02-03
PREMIUM, SHELTA Implant Systems (K142242)Sweden & Martina S.P.A.2015-02-02
LISTERINE Sensitivity Defense Mouthrinse (K143155)Johnson & Johnson Healthcare Products, Division of Mcneil-Pp2015-01-29
WINSIX Implant System (K133733)Biosaf IN S.R.L.2015-01-28
DCCERAM SYSTEM (K141400)Ceramay GmbH & Co.Kg2015-01-28
PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) (K142625)Kuraray Noritake Dental, Inc.2015-01-27
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System (K142572)Zimmer Dental, Inc.2015-01-21
OPTIMUS CMF SYSTEM (K140037)Osteonic Co., Ltd.2015-01-20
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (K142890)Straumann USA, LLC2015-01-09
S200, S300 (K133412)Cefla S.C.2015-01-08
BioHorizons Tapered Internal Implants (K143022)BioHorizons Implant Systems, Inc.2015-01-08
Ufi Gel hard C (K143486)Voco GmbH2015-01-07
Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm (K142667)Sterngold Dental, LLC2015-01-07
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X (K141923)Prismatik Dentalcraft, Inc.2015-01-06
zenostar MO, Zenostar T, Zenostar VisualiZr (K142233)Wieland Dental + Technik GmbH & Co. KG2015-01-05
ZX-27 (K133088)M&M Dental Studio, Inc.2015-01-02
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM (K142124)Aseptico, Inc.2014-12-31
Straight Stud Attachment (K142407)Sterngold Dental, LLC2014-12-24
NORIS MEDICAL DENTAL IMPLANTS SYSTEM (K140440)Noris Medical , Ltd.2014-12-19
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM (K140978)Osteomed2014-12-18
DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) (K141727)Liaoning Upcera Co., Ltd.2014-12-18
TRISTAR BONE GRAFT FIXATION SYSTEM (K141764)Impladent , Ltd.2014-12-18
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA (K142043)Jensen Industries, Inc.2014-12-18
LUMINESSE PORCELAIN SYSTEM (K140848)Talladium, Inc.2014-12-17
The Panthera Anti-Snoring Device (K143244)Panthera Dental, Inc.2014-12-15
BruxZir Anterior (K143330)Prismatik Dentalcraft, Inc.2014-12-15
TRAUSIM DENTAL IMPLANT SYSTEM (K140202)Jiangsu Trausim Medical Instrument2014-12-12
THERASNORE (K140663)Distar, LLC2014-12-12
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL (K140350)Preventive Technologies, Inc.2014-12-12
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM (K140091)Megagen Implant Co., Ltd.2014-12-12
LYTHOS DIGITAL IMPRESSION SYSTEM (K141611)Ormco Corp.2014-12-05
MARK3 (K141092)Cavex Holland BV2014-12-04
Variolink Esthetic (K142389)Ivoclar Vivadent, AG2014-11-25
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE (K142118)Prismatik Dentalcraft, Inc.2014-11-25
Collagen Dental Membrane - Conformable IIBP (K142496)Collagen Matrix, Inc.2014-11-24
SGS DENTAL IMPLANT (K133362)Sgs International, Ltd.2014-11-21
PREMIER ETCH (K141839)Premier Dental Products Co.2014-11-17
BULK FILL FLOWABLE COMPOSITE (K141994)Novocol, Inc.2014-11-14
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT (K142115)Prismatik Dentalcraft, Inc.2014-11-13
HIOSSEN IMPLANT SYSTEM (K140934)Hiossen, Inc.2014-11-12
COMPOSITE ORTHODONTIC BRACKETS (K140807)Ortho Specialties2014-11-12
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS (K141457)Dentium Co., Ltd.2014-11-12
DENALI 501CEMENT (K141503)Denali Corporation2014-11-10
OBSIDIAN PRESS (ALL CERAMIC AND POM) (K141887)Prismatik Dentalcraft, Inc.2014-11-06
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP (K141909)Collagen Matrix, Inc.2014-11-05
ICE ZIRKON TRANSLUZENT (K132230)Zirkonzahn Srl2014-11-05
GUIDOSS (K133507)Nibec Co., Ltd.2014-11-05
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K141700)Genoray Co., Ltd.2014-10-31
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM (K140293)Adin Dental Implants Systems , Ltd.2014-10-31
J2I IMPLANT SYSTEM (K140052)Kj Meditech Co., Ltd.2014-10-30
Miltex N-Tralig Intraligamentary Syringe (K142414)Integra LifeSciences Corporation2014-10-30
KJ EXTERNAL IMPLANT SYSTEM (K140051)Kj Meditech Co., Ltd.2014-10-30
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR (K141221)Lares Research, Inc.2014-10-28
#8C RENEGADE DENTAL HANDPIECE (K142063)Handpiece Club, LLC2014-10-28
ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT (K142082)Zimmer Dental, Inc.2014-10-28
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (K133069)Codent Technical Industry Co., Ltd.2014-10-24
CLINPRO PROPHY POWDER (K140684)3M Deutschland GmbH2014-10-24
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE (K141125)Handpiece Headquarters2014-10-23
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS (K141211)Prismatik Dentalcraft, Inc.2014-10-22
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK (K141724)Liaoning Upcera Co., Ltd.2014-10-22
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM (K141544)Zimmer Dental, Inc.2014-10-22
UPCERA COLORING LIQUID (I AND II ) (K141723)Liaoning Upcera Co., Ltd.2014-10-22
Vericore Zirconia Blanks (K142670)Whip Mix Corporation2014-10-22
IONOSTAR MOLAR (K140993)Voco GmbH2014-10-20
MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR (K140728)Ditron Precision, Ltd.2014-10-17
MATRIXWAVE MMF SYSTEM (K141165)Synthes (USA) Products, LLC2014-10-17
NDX DORSAL APPLIANCE (K133390)Institute For Quality Resource Management2014-10-16
PIEZOMED (K133488)W&H Dentalwerk Buermoos GmbH2014-10-16
PRISM ZIRCONIA, ST-98 (K141659)A & D Dental Innovations2014-10-09
FLUOR PROTECTOR S (K131487)Ivoclar Vivadent, AG2014-10-08
LED CURING LIGHT (K133040)Monitex Industrial Co., Ltd.2014-10-07
JUGGERKNOT MINI SOFT ANCHOR (K140908)Biomet Sports Medicine2014-10-02
PROFLUORO FLUORIDE VARNISH (K141422)Pac-Dent International, Inc.2014-09-30
STARBRIGHT 5% SODIUM FLUORIDE VARNISH (K140349)Nanova Biomaterials, Inc.2014-09-22
ENDO SMART (K133298)Meta Biomed, Inc.2014-09-19
ONE PLUS IMPLANT SYSTEM (K133050)Osseofuse, Inc.2014-09-19
IROOT FM (K130312)Innovative Bioceramix, Inc.2014-09-18
AXIOM 2.8 (K141450)Anthogyr Sas2014-09-17
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT (K141018)Procter & Gamble Co.2014-09-15
M-PM-DISC (PINK) (K140758)Merz Dental GmbH2014-09-15
ORTHODONTIC ACRYLIC (NOT FINALIZED) (K141439)Bisco, Inc.2014-09-12
CRANE ACRYLIC HERBST APPLIANCE (K140429)Crane Dental Laboratory, Inc.2014-09-11
MSN-006 (K141562)GC America, Inc.2014-09-05
AJAX DENTAL UNIT (K132245)Pro Dental Services, LLC2014-09-05
SOPIX INSIDE, SOPIX2 INSIDE (K140013)Sopro - Acteon Group2014-09-05
PHOT-X IIS MODEL 505 (K141293)Takara Belmont Corporation2014-09-03
VERICORE ZIRCONIA BLANKS (K140877)Whip Mix Corp.2014-09-03
ALL-CERAMIC ZIRCONIA BLOCK (K141162)Rizhao Huge Dental Industry Co., Ltd.2014-08-27
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) (K141497)Osstem Implant Co., Ltd.2014-08-26
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM (K133592)Neodent USA, Inc.2014-08-22
SB ANCHOR (K140600)Osstem Implant Co., Ltd.2014-08-21
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM (K133706)Zl Microdent-Attachment GmbH & Co. KG2014-08-21
OBSIDIAN MILLING BLOCKS (K141788)Prismatik Dentalcraft, Inc.2014-08-20
TENURE4G (K140537)Den-Mat Holdings, LLC2014-08-20
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