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Dental

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

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RecordFirmDate
Cybird LED Curing Light (K173876)Dxm Co., Ltd.2018-01-24
TruAbutment DS (K172304)Truabutment, Inc.2018-01-23
Angel Align System (K171674)Smile Development Corp2018-01-19
Straumann Dental Implant System (K171784)Straumann USA, LLC2018-01-19
PROPEL Device (K172164)Propel Orthodontics, LLC2018-01-17
OBA-MCP, Orthodontic Bracket Adhesive with MCP (K173020)Pulpdent Corporation2018-01-17
Ortho System (K171634)3Shape A/S2018-01-17
Yamahachi Pink CAD/CAM Disk (K172683)YAMAHACHI DENTAL MFG., Co.2018-01-16
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel (K172977)Nanova Biomaterials, Inc.2018-01-16
Elos Accurate Customized Abutment, Elos Prosthetic Screw (K171799)Elos Medtech Pinol A/S2018-01-15
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (K171958)Mectron S.P.A.2018-01-12
Dentium Ti-Base (K171622)Dentium Co., Ltd.2018-01-11
CEREC Ortho Software (K171122)Dentsply Sirona2018-01-11
ET Hybrid Abutment (K170421)Hiossen, Inc.2018-01-11
ULab Systems Treatment Planning Software (K171295)Ulab Systems, Inc.2018-01-09
STRONG Dental Handpieces (K171436)Saeshin Precision Co., Ltd.2018-01-05
Sureclear aligners (K171860)Emergo Global Consulting, LLC2018-01-05
Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169)Pulpdent Corporation2018-01-05
BIO-C SEALER (K172701)Angelus Industria DE Produtos Odontologicos S/A2018-01-04
Straumann CARES Abutments CoCr (K172798)Institut Straumann AG2018-01-03
Snorer's Friend (K171529)Scope Healthcare Technologies Pty, Ltd.2018-01-02
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (K172505)Mis Implants Technologies , Ltd.2017-12-28
COMPACT S, COMPACT S (LED) (K170104)Dmetec.Co., Ltd.2017-12-27
PREMIUM ONE Implant Systems (K172560)Sweden & Martina S.P.A.2017-12-21
Well-Root ST (K170950)Vericom Co., Ltd.2017-12-20
FS Ergo (K173646)Palodex Group OY2017-12-19
PEEK Biosolution (K173124)Merz Dental GmbH2017-12-18
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) (K172918)Kavo Dental Technologies, LLC2017-12-18
PERIO-FLOW nozzle (K171174)E.M.S Electro Medical Systems S.A2017-12-18
NobelPerfect Abutments (K172854)Nobel Biocare AB2017-12-14
Fixtemp C&B (K171729)Dreve Dentamid GmbH2017-12-13
Prodigio Stain Powder (K171167)Operart, LLC2017-12-13
TSV BellaTek Encode Healing Abutments (K173374)Biomet 3i2017-12-13
W&H Assistina Twin (K171553)W&H Dentalwerk Buermoos GmbH2017-12-08
BEAUTIFIL Flow Plus X (K172530)Shofu Dental Corporation2017-12-06
Renamel Microfill (K172707)Cosmedent, Inc.2017-12-05
IR Type Implant System (K171185)Biotem Co., Ltd.2017-12-01
S.I.N. Implant System (K170392)S.I.N. – Sistema DE Implante Nacional S.A.2017-12-01
Straumann n!ce Glass Ceramic A14 Blocks (K171773)Institut Straumann AG2017-12-01
Atlantis Abutment for MIS Implant (K172225)Dentsply Sirona2017-11-30
s-Clean TiN Coating Abutments (K171694)Dentis Co., Ltd.2017-11-29
NobelDesign, DTX Studio Design (K171466)Nobel Biocare AB2017-11-29
Meridian PM (K170053)The Center For Craniofacial & Dental Sleep Medicine2017-11-28
DIAZIR (K161652)Zxtgy (Beijing) Technology Co., Ltd.2017-11-28
TOKUYAMA UNIVERSAL BOND (K171226)Tokuyama Dental Corporation2017-11-28
Straumann Screw Retained Abutments (K171757)Straumann USA, LLC (On Behalf of Institut Straumann Ag)2017-11-27
LED Curing Light (K161855)Monitex Industrial Co., Ltd.2017-11-27
True Function Adjustable Herbst Appliances (K170578)True Function Laboratory, Inc.2017-11-24
DENTCA DENTURE Teeth (K172398)Dentca, Inc.2017-11-22
BioHorizons Tapered Short Implants (K172576)BioHorizons Implant Systems, Inc.2017-11-22
CamX Triton HD Proxi Head (K172007)Duerr Dental AG2017-11-22
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (K172859)Prosomnous Sleep Technologies2017-11-22
KLS Martin Individual Patient Solutions (K163579)KLS Martin L.P.2017-11-21
Parkell Universal Adhesive (K172176)Parkell, Inc.2017-11-21
Dental Low-speed Turbine Handpiece (K170236)Guangdong Jinme Medical Technology Co., Ltd.2017-11-21
Surgical Angle Handpiece, Surgical Straight Handpiece (K171155)Nakanishi, Inc.2017-11-21
Ultrasonic scaler (K163414)Nanning VV Dental Co., Ltd.2017-11-21
S.I.N. Dental Implant System (K170398)S.I.N. – Sistema DE Implante Nacional S.A.2017-11-21
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) (K172761)Shanghai New Century Dental Materials Co., Ltd.2017-11-17
Acrylic Herbst Appliance with Micro-Recorder (K170606)Gergen'S Orthodontic Lab2017-11-16
Klockner Vega TiBase for CEREC (K170022)SOADCO, S.L.2017-11-16
LeEject 2 Dental Syringe and Needle System (K171254)Advanced Technology and Capital, Inc.2017-11-16
KaVo NOMAD Pro 2 Handheld X-ray System (K173319)Aribex2017-11-16
Registrado Scan (K171815)Voco GmbH2017-11-15
n!ce for Planmill (K173410)Institut Straumann AG2017-11-14
Straumann PURE Ceramic Implants (K171769)Straumann USA, LLC (On Behalf of Institut Straumann Ag)2017-11-14
Pekkton Ivory (K170102)Cendres+Metaux SA2017-11-13
Geistlich Fibro-Gide (K171050)Geistlich Pharma AG2017-11-09
J2A SLA Dental Implant System (K161923)Kj Meditech Co., Ltd.2017-11-09
Stryker Universal Mesh (K170773)Stryker2017-11-08
Dental High-speed Turbine Handpiece (K170229)Guangdong Jinme Medical Technology Co., Ltd.2017-11-08
External Hex Implants (K163634)Southern Implants (Pty), Ltd.2017-11-06
Neodent Implant System - CM Pro PEEK Abutment (K170080)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2017-11-02
Duracetal (K172407)The Myerson Company Limited2017-11-02
Rapid HB, Rapid LB, Rapid MB (K173318)3M Deutschland GmbH2017-10-31
Stryker Upper-Face AXS screws and Mid-Face AXS screws (K172572)Stryker2017-10-31
Anorganic Bone Mineral with Collagen in Delivery Applicator (K171008)Collagen Matrix, Inc.2017-10-30
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed (K171643)Geistlich Pharma AG2017-10-30
Healing Cap Multi-Unit Titanium (K171142)Nobel Biocare AB2017-10-26
Cocoon Portable Handheld X-Ray System (K173046)Dexcowin Co., Ltd.2017-10-26
Intra-Lock Bone Fixation System (K171831)Intra-Lock International, Inc.2017-10-26
TREFOIL System (K172352)Nobel Biocare AB2017-10-20
Premium Plus Prophy Air Motor (K170261)Premium Plus International Limited2017-10-19
PuRE PMMA Disc (K172281)Quest Dental USA Corp.2017-10-19
RPM Reinforced PTFE Mesh (K171774)Osteogenics Biomedical, Inc.2017-10-19
CERABIEN ZR (K170834)Kuraray Noritake Dental, Inc.2017-10-17
Kisses Mini (K170394)Achimhai Medical Corporation2017-10-06
Nobilplast Denture Resin (K170375)Cmp Industries, LLC2017-10-02
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl (K170873)Swissmeditec GmbH2017-10-02
Thommen Implant System (K171795)Thommen Medical AG2017-09-29
MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm (K171728)Sterngold Dental, LLC2017-09-28
Anatotemp Anatomic Dental Implant Healing Abutment (K171922)Buckeye Medical Technologies, LLC2017-09-28
Straumann CARES Golden Ti/TiN Abutments (K162848)Institut Straumann AG2017-09-22
Eztetic BellaTek Encode Healing Abutments (K170013)Biomet 3i2017-09-21
Ceramill Zolid HT+ white (K171876)Amann Girrbach AG2017-09-20
A.B. DENTAL DEVICES Dental Implants System (K162482)A.B. Dental Device , Ltd.2017-09-15
Medentika CAD/CAM TiBases (K170838)Medentika GmbH2017-09-15
AIR-FLOW PLUS Prophylaxis powder (K171189)E.M.S Electro Medical Systems S.A2017-09-11
Electronic Caries Detector (K170822)Ortek Therapeutics, Inc.2017-09-11
Tri Auto ZX2 (K170275)J. Morita USA, Inc.2017-09-11
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