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Dental

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

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RecordFirmDate
The Moses Express appliance (K142651)Allen J. Moses, Dds, Ltd.2015-07-17
INTEGO Family and Accesories (K150909)Sirona Dental Systems GmbH2015-07-17
2014 InterActive/SwishActive System (K143011)Implant Direct Sybron Manufacturing, LLC2015-07-16
GC Ortho Connect, GC Ortho Etching Gel (K150128)Gc Orthodontics America, Inc.2015-07-16
ArgenZ Esthetic Plus (K150919)The Argen Corporation2015-07-13
Neodent Implant System (K150367)Jjgc Industria E Comercio DE Materiais Dentarios S2015-07-13
StarCeram® Z-Nature, StarCeram® Z-Smile (K143656)H.C. Starck Ceramics GmbH2015-07-09
iBond Universal & iBond Ceramic Primer (K150933)Heraeus Kulzer, LLC, Mitsui Chemicals Group2015-07-07
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (K150750)Sirona Dental Systems GmbH2015-07-02
Biodenta Customized Abutment-Hybrid (K150296)Biodenta Swiss AG2015-07-02
BruxZir Anterior Milling Blanks (K150872)Prismatik Dentalcraft, Inc.2015-07-02
Admira Fusion (K150784)Voco GmbH2015-07-02
NOVA Dental Implants System (K150363)Nova Implants , Ltd.2015-06-29
TRAUS ENDO (K143411)Saeshin Precision Co., Ltd.2015-06-29
Nacera Pearl (K143071)Doceram Medical Ceramics GmbH2015-06-26
Zimmer Patient-Specific Abutment, Internal Hex, Titanium (K143505)Zimmer Dental, Inc.2015-06-25
Fill-Up! (K150218)Coltene/Whaledent AG2015-06-23
Jade 37% Phosphoric Acid Etchant Gel (K150696)Dharma Research, Inc.2015-06-23
Dental Bone Cutting Instruments (K150796)Synthes (USA) Products, LLC2015-06-23
Life Fast Set, Life Regular Set (K150559)Sybron Dental Specialties2015-06-19
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (K150369)Somnomed, Inc.2015-06-18
Nanova Flowable Composite (K150623)Nanova Biomaterials, Inc.2015-06-18
ZIBONE ZIRCONIA BLOCKS (K140836)Coho Technology Co., Ltd.2015-06-17
ESTECEM (K150727)Tokuyama Dental Corporation2015-06-17
Cavitron Touch Ultrasonic Scaling System (K150535)Dentsply International, Inc.2015-06-16
LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090)Talladium, Inc.2015-06-15
Chang Gung ComMed Series Dental Implant System (K142751)Chang Gung Medical Technology Co., Ltd.2015-06-15
Neodent Implant System (K150199)Jjgc Industria E Comercio DE Materiais Dentarios S2015-06-15
SternSnap Angled Attachment (K150250)Sterngold Dental, LLC2015-06-11
GBR System (K143730)Jeil Medical Corporation2015-06-10
TETRIC EVOFLOW BULK FILL (K150393)Ivoclar Vivadent, AG2015-06-09
TI-OSS (K140021)Chiyewon2015-06-05
CreoDent Solidex Customized Abutment (K150012)Creodent Prosthetics, Ltd.2015-06-04
Fixtemp Cement (K142446)Exacta Dental Direct, Inc.2015-06-04
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (K150076)Dong IL Technology , Ltd.2015-06-02
Fiber Disks and Blocks (TRINIA) (K143524)Bicon, LLC2015-06-02
MICRODENT GENIUS IMPLANT SYSTEM (K141188)Implant Microdent2015-06-02
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) (K150129)Aseptico, Inc.2015-05-28
Mandible External Fixator - MR Conditional (K143285)Synthes USA Products, LLC2015-05-28
Coating Material (K150511)Sun Medical Co., Ltd.2015-05-27
Acryfree Denture Base Material and Biosens Denture Base Material (K150454)Perflex2015-05-26
Somnowell Mandibular Advancement Appliance (MAA) (K150941)Somnowell , Ltd.2015-05-22
TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS (K140491)Tanaka Dental2015-05-20
Chi Lites Orthodontic Sapphire Bracket (K142729)Progressive Technology, Inc.2015-05-15
Rhondium One-Visit-Crown(OVC) (K143694)Rhondium, Ltd.2015-05-15
T.A.G. Dental Implant System (K143326)T.A.G. Medical Products Corporation, Ltd.2015-05-14
MDK HANDPIECES (K141886)Modern Korea Co., Ltd.2015-05-13
NobelActive (K142260)Nobel Biocare AB2015-05-11
GC KommonBase (K143667)Gc Orthodontics America, Inc.2015-05-07
Luxisse+ (K150056)Heany Industries, Inc.2015-05-06
Stryker MEDPOR TITAN 3D Orbital Floor Implant (K142568)Stryker2015-05-05
Maxima PRO 45L (K141576)Kavo DO Brasil Industria E Comercio Ltda2015-05-04
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System (K143528)Zimmer Dental, Inc.2015-05-01
Bifix Temp (K143212)Voco GmbH2015-05-01
Sonendo GentleWave System (K143448)Sonendo, Inc.2015-05-01
Nuance FLOW (K143679)Den-Mat Holdings, LLC2015-05-01
Digital Dental Intra Oral Sensor, EzSensor Smart (K150797)Rayence Co., Ltd.2015-05-01
Codent Low Speed Dental Handpieces and Accessories (K150798)Codent Technical Industry Co., Ltd.2015-04-24
KI-20 (K141482)Saeyang Microtech Co., Ltd.2015-04-24
Luminesse PMMA (K142371)Talladium, Inc.2015-04-24
Neodent Implant System- CM Drive Implants (K150182)Jjgc Industria E Comercio DE Materiais Dentarios S2015-04-23
RAYSCAN A-EXPERT (K142058)Ray Co., Ltd.2015-04-22
G-Premio BOND (K143140)GC America, Inc.2015-04-20
UnicLine Mobile (K150490)Heka Dental A/S2015-04-17
Dorsal Appliance (K143591)Gergens Orthodontic Lab2015-04-15
Acrylic Block (K143265)Sun Medical Co., Ltd.2015-04-14
LC CALCIUMHYDROXIDE LINER (K141047)S&C Polymer Silicon- Und Composite Spezialitaeten2015-04-14
Neoss Ti Reinforced Membrane (K143327)Neoss, Ltd.2015-04-13
MASTERmatic LUX (K143465)Kaltenbach & Voigt GmbH2015-04-09
ULTRASONIC SCALER (K140233)Nanning Baolai Medical Instrument Co., Ltd.2015-04-06
Accu-Dent XD Tray, Accu-Dent XD Syringe (K143575)Ivoclar Vivadent, Inc.2015-04-03
Monobond Etch & Prime (K150164)Ivoclar Vivadent, AG2015-04-03
Hahn Tapered Implant System (K143353)Prismatik Dentalcraft, Inc.2015-04-02
J2A Dental Implant System, J2C Dental Implant System (K150060)Kj Meditech Co., Ltd.2015-04-02
Argulated Locking Plates (K143338)Osteomed LP2015-04-01
Biomet Microfixation OmniMax MMF System (K143336)Biomet Microfixation2015-04-01
EBI External Implant System (K142426)Ebi, Inc.2015-03-27
DD cubeX2 (K150196)Dental Direkt GmbH2015-03-26
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (K143104)Kettenbach GmbH & Co. KG2015-03-25
IBS IMPLANT SYSTEM (K140806)Innobiosurg Co., Ltd.2015-03-23
BIOMATE DENTAL IMPLANT SYSTEM (K142174)Biomate Medical Devices Technology Co., Ltd.2015-03-20
SYNTEC WETALI ORTHODONTIC MINI SCREWS (K142001)Syntec Scientific Corporation - Taipei Office2015-03-18
NICAL SMART MICRO CR system for intraoral dental images (K143703)Nical Spa2015-03-18
DMRC Self-Cure Bracket Adhesive One Step and Primer (K142886)Danville Materials, LLC2015-03-18
Dental Unit (K142206)Zhuhai Siger Medical Equipment Co., Ltd.2015-03-13
KONUS DENTAL IMPLANT SYSTEM (K141159)Argon Med. Productions Vertriebs Gesellschaft Mbh2015-03-11
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio (K143753)Rayence Co., Ltd.2015-03-10
PACSEAL PIT & FISSURE SEALANT (K141717)Pac-Dent International, Inc.2015-03-09
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES (K141183)Ttbio Corp.2015-02-27
KATANA Zirconia (K143439)Kuraray Noritake Dental, Inc.2015-02-27
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED (K140990)E.M.S Electro Medical Systems S.A2015-02-27
PROROOT MTA WHITE, PROROOT MTA GRAY (K142178)Dentsply International, Inc.2015-02-26
PANAVIA SA Cement Plus Handmix (K142623)Kuraray Noritake Dental, Inc.2015-02-26
T-8000 THEROZONE UNIT (K141504)Therozone USA, Inc.2015-02-24
EAZY PRIMER (K142848)Parkell, Inc.2015-02-24
DentiAnn Smart Sil (K143382)Seilglobal Co., Ltd.2015-02-23
MEDENTIKA ABUTMENT SYSTEM (K142167)Medentika GmbH2015-02-20
Osstell IDx (K142358)Osstell AB2015-02-19
CONELOG Titanium base CAD/CAM (K143337)Altatec GmbH2015-02-17
Maxima XTEND Handpiece Maintenance System (K143183)Handpiece Headquarters2015-02-17
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