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Dental

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

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RecordFirmDate
Neodent Implant System - Mini Abutment 60° (K203542)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-08-02
FiteBac CC OrthoSeal (K210115)Largent Health, LLC2021-07-29
CRUXVIEW (K211317)Cruxell Corp.2021-07-29
BTI Extra-Short Dental Implant System UnicCa (K202825)B.T.I. Biotechnology Institute, Sl.2021-07-29
Portray (K211014)Surround Medical Systems2021-07-28
Neocis Guidance System (NGS) with Intraoral Fiducial Array (K211129)Neocis, Inc.2021-07-28
MIS Ti-base abutment (K211225)Dentsply Sirona2021-07-28
Pac-Dent Denture Base Resin (K210189)Pac-Dent, Inc.2021-07-28
Dental Impression Material (K211489)Nanchang Dental Bright Technology Co., Ltd.2021-07-28
1Derful HS, 1Derful HT (K210884)1derful, Inc.2021-07-27
Pac-Dent Ceramic Nanohybrid Resin (K210412)Pac-Dent, Inc.2021-07-26
IS Multi Unit Abutment System (K210903)Neobiotech Co., Ltd.2021-07-23
DC-Air and Athlos-1 and Athlos-Air (K211688)Athlos OY2021-07-22
AbutmentCAD (K193352)Exocad GmbH2021-07-21
The Slide (K203712)Biotex, Inc.2021-07-20
TKO Composite Bite Turbo Gel (K210349)Reliance Orthodontic Products, Inc.2021-07-20
PacBond One (K210186)Pac-Dent, Inc.2021-07-16
TERA HARZ (K202846)Graphy, Inc.2021-07-15
OsteoSync™ Ti Dental Mesh (K202918)Sites Medical, LLC2021-07-14
UltraTemp Rez II (K211237)Ultradent Products, Inc.2021-07-13
TruAbutment DS, TruBase (K202579)Truabutment, Inc.2021-07-08
Ultra SEP (K210945)Reliance Orthodontic Products, Inc.2021-07-08
Straumann RidgeFit Implants (K211052)Institut Straumann AG2021-07-08
TRIOCLEAR System (K193622)Perfection Aligner System Hong Kong Limited2021-07-06
NUVO CF Implant System (K203309)JJGC Indústria e Comércio de Materiais Dentários S.A.2021-07-06
Estar-Z (K210097)Osstem Implant Co., Ltd.2021-07-02
Snore Bandit (K210910)Snorebandit, LLC2021-07-01
MAZIC Claro CAD and MAZIC Claro Press (K203672)Vericom Co., Ltd.2021-07-01
Metapaste Plus (K210904)Meta Biomed Co., Ltd.2021-06-30
Diafil & Diafil Capsule (K210421)DiaDent Group International2021-06-28
CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353)Centermed, Inc.2021-06-28
Perfit FS Dental Zirconia Fully Sintered Block (K203590)Vatech Acucera, Inc.2021-06-24
Renamel Bulkfill (K211259)Cosmedent, Inc.2021-06-24
Straumann CARES M-Series CAD/CAM System (K203456)Institut Straumann AG2021-06-23
S.I.N. Dental Implant System (K203725)S.I.N. - Sistema DE Implante Nacional S.A.2021-06-23
AnyOne Onestage Implant System (K210161)Megagen Implant Co., Ltd.2021-06-22
Orthodontic Facemask (K202855)Ita.O Italian Orthodontic System S.R.L.2021-06-21
Straumann BLX Implant System (K210855)Institut Straumann AG2021-06-21
coDiagnostiX (K193301)Dental Wings GmbH2021-06-21
Kontact Dental Implant System (K210220)Biotech Dental, Sas2021-06-18
MIS Lance+ Conical Connection Dental Implant System (K210886)Dentsply Sirona2021-06-17
Silent Nite Sleep Appliance with the Glidewell Hinge (K210694)Prismatik Dentalcraft, Inc.2021-06-16
E-Temp (K211101)Envisiontec GmbH2021-06-14
PANAVIA Veneer LC (K210504)Kuraray Noritake Dental, Inc.2021-06-11
HIT Clear Aligner (K210613)Cdb Corporation2021-06-04
TruBase S (K201842)Truabutment, Inc.2021-06-04
Dentis s-Clean s-Line Mini (K210080)Dentis Co., Ltd.2021-06-04
6MS Invisible Aligner (K210652)Sms Opco, LLC2021-06-02
Implacil Implant System (K202832)Implacil DE Bortoli Material Odontologico Ltda2021-05-26
E-Dent 1000 (K210977)Envisiontec GmbH2021-05-25
Tokuyama Universal Bond II (K203760)Tokuyama Dental Corporation2021-05-25
Impla-NX (Model: ISE-270M) (K201192)Micro-Nx Co., Ltd.2021-05-21
Ohlendorf Clear Aligner (K210540)Ohlendorf Appliance Laboratory2021-05-19
TECHFIT Patient-Specific Maxillofacial System (K203282)Industrias Medicas Sampedro S.A.S2021-05-19
BoneTrust Mini Implant System (K200573)Medical Instinct Deutschland GmbH2021-05-14
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (K200555)Prevest Denpro Limited2021-05-13
Endo Motor (K203320)Guilin Woodpecker Medical Instrument Co., Ltd.2021-05-10
GR-14 Resin System (K210298)Pro3Dure Medical GmbH2021-05-05
AccelX Abutments (K203240)Integrated Dental Systems, LLC2021-04-27
Illusion Aligners (K211010)Laxmi Dental Exports Pvt, Ltd.2021-04-26
VSP System (K210347)3D Systems2021-04-26
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190)3M Company, Unitek Orthodontic Products2021-04-23
PlutoX Digital Intraoral X-Ray Imaging System (K210312)Iray Technology Taicang , Ltd.2021-04-23
IDCAM Dental Implants (K200329)Implants Diffusion International2021-04-22
Dentis s-Clean s-Line (K210134)Dentis Co., Ltd.2021-04-19
VPS Impression Material (K203824)Hygedent, Inc.2021-04-19
Locator Overdenture Implant System (K203701)Ivory Super Holdco Inc. / Zest Anchors, LLC2021-04-15
Metapex Plus (K202617)Meta Biomed Co., Ltd.2021-04-14
EndoPilot2 (K202906)Schlumbohm GmbH & Co. KG2021-04-13
PuRE PMMA Disc (K201563)Quest Dental USA Corp.2021-04-09
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank (K203499)Vatech Acucera, Inc.2021-04-05
CreoDent Solidex Customized Abutment (K202909)Creodent Prosthetics, Ltd.2021-04-02
Porcine Mineral Collagen Composite (K202183)Collagen Matrix, Inc.2021-04-02
E-Denture Pro (K203641)Envisiontec GmbH2021-03-30
LumiCare Caries Diagnostic Rinse (K200601)GreenMark Biomedical, Inc.2021-03-29
TruAbutment DS, TruBase S (K201197)Truabutment, Inc.2021-03-26
DiaPaste (K210333)DiaDent Group International2021-03-25
White ENDOSEAL MTA (K202015)Maruchi2021-03-24
DIOnavi-Denture02 (K210828)Dio Corporation2021-03-23
Spark Clear Aligner System (K203737)Ormco Corporation2021-03-22
SensorX (K203116)Durr Dental SE2021-03-19
HySil Plus Impression Materials (K210041)Osstem Implant Co., Ltd.2021-03-18
s-Clean SQ-SL Implant System Mini (K202773)Dentis Co., Ltd.2021-03-18
Straumann Immediate Temporary Abutments (K201681)Institut Straumann AG2021-03-18
Multi-unit Abutments for CONELOG (K203252)BioHorizons Implant Systems, Inc.2021-03-16
Neodent Implant System-Easy Pack (K203382)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-03-15
VENUS Bracket, ROSE Bracket (K201410)Gni Co., Ltd.2021-03-12
Endo Motor (K192649)Foshan Cicada Dental Instrument Co, Ltd.2021-03-12
Non-Sterile Zirconia Block (K201492)Bioden Co., Ltd.2021-03-10
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) (K203606)Meris Investment Group2021-03-10
Perfit ZR HT Dental Zirconia blank (K203351)Vatech Acucera, Inc.2021-03-08
Geistlich Mucograft®, Geistlich Mucograft® Seal (K210280)Geistlich Pharma AG2021-03-03
VALO Grand Corded and Accessory Lenses (K210550)Ultradent Products, Inc.2021-03-01
AsoAligner (K201104)Aso International Manila, Inc.2021-02-26
Archworx (K173738)Utah Medical Products and Services2021-02-26
Classic (K203477)Orthoapnea S.L.2021-02-25
PROXEO Twist Cordless Polishing System PL-40 H (K201703)W&H Dentalwerk Buermoos GmbH2021-02-24
GenesisZr 4Y+ (ST1100) Zirconia (K201915)United Dental Resources Corporation2021-02-23
Inbrace Orthodontic System (K203442)Swift Health Systems, Inc.2021-02-19
Advanced Dental Appliance (K203462)Dasoft Partners2021-02-19
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