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Dental

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

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RecordFirmDate
Elos Accurate Hybrid Base (K201860)Elos Medtech Pinol A/S2021-02-19
s-Clean SQ-SL Implant System Regular (K210132)Dentis Co., Ltd.2021-02-17
Straumann Variobase C (K192742)Institut Straumann AG2021-02-12
MedCAD® AccuPlate® Patient-Specific Plate (K193280)Medcad2021-02-12
CleaniCal (K201799)Maruchi2021-02-12
NOA Sleep Apnea and Snoring Device (K202651)Orthoapnea S.L.2021-02-12
Straumann TLX Novaloc and Cementable Abutments (K203355)Institut Straumann AG2021-02-12
EDS Bioceramic Sealer (Bioseal) (K202281)Essential Dental Systems2021-02-12
DSP Implant System (K192839)D.S.P Industrial Eireli2021-02-11
TRAUS SIP20 (K201292)Saeshin Precision Co., Ltd.2021-02-11
Bio-C Repair Ion+ (K201222)Angelus Industria DE Produtos Odontologicos S/A2021-02-11
Straumann 4 mm Short Implants (K202942)Straumann USA, LLC2021-02-08
GentleWave X (K203302)Sonendo, Inc.2021-02-05
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) (K203374)De Götzen S.R.L.2021-02-05
eXciteOSA with remote and eXciteOSA without remote (DEN200018)Signifier Medical Technologies2021-02-05
Shofu Block HC Hard (K200470)Shofu Dental Corporation2021-02-05
Omnichroma Flow Bulk (K203598)Tokuyama Dental Corporation2021-02-03
E-connect S Endo Motor with built-in Apex Locator (K201993)Changzhou Sifary Medical Technology Co., Ltd.2021-01-29
Neodent Implant System - Zirconia Implant System (K202282)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-01-29
GenesisZr UHT700 Zirconia (K201608)United Dental Resources Corporation2021-01-28
Cytoplast Titanium-Reinforced PTFE Membranes (K201187)Osteogenics Biomedical, Inc.2021-01-23
BRIUS Clear Aligners (K202792)Brius Technologies, Inc.2021-01-22
Simply Iconic Implants (K201553)Implant Direct Sybron Manufacturing, LLC2021-01-22
Dentsply Sirona Universal Spray Glazes (K202629)Dentsply Sirona2021-01-20
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (K192913)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2021-01-19
Vital Sleep (K201719)The Snore Reliever Company, LLC2021-01-14
BEGO Semados® RS/RSX Implant System (K201700)Bego Implant Systems GmbH & Co. KG2021-01-13
Striate+™ (K201241)Orthocell, Ltd.2021-01-11
OBS Anchorage Screw, Biokey Anchorage Screw (K202278)Bomei Co, Ltd.2021-01-08
NEOLab Clear Aligners (K203339)New England Ortho Lab, Inc.2021-01-06
ClearPath Aligner (K202857)Clearpath Orthodontics, Ltd.2021-01-05
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) (K201800)Nanoray Co., Ltd.2020-12-28
iSMILE (K200908)3D Diagnostix, Inc.2020-12-22
Neodent Implant System - Zirconia Implant System (K201491)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-12-22
Opallis, Opallis Flow (K201707)Dentscare Ltda2020-12-22
PlaniMax Orthodontic Software (K201036)Choice Biotech, Inc.2020-12-22
Blue Sky Bio CAD-CAM Abutments (K202026)Blue Sky Bio, LLC2020-12-18
Blue Sky Bio TAD (K201919)Blue Sky Bio, LLC2020-12-17
Aidite PMMA (K190217)Aidite (Qinhuangdao) Technology Co., Ltd.2020-12-17
CreoDent Solidex Customized Abutment and Screw (K202095)Creodent Prosthetics, Ltd.2020-12-16
Neocis Guidance System (NGS) with Patient Splints (EPS) (K203401)Neocis, Inc.2020-12-15
X-cera Pre-shaded Zirconia Blanks (K202673)Dongguan Xiangtong Co., Ltd.2020-12-10
CARES Screw - Retained Bars and Bridges (SRBB) (K201711)Medentika GmbH2020-12-08
TTBIO EVOCLEAN Ultrasonic Scaler (K201317)Ttbio Corp.2020-12-04
Neocis Guidance System (NGS) with Yomi Plan v2.0 (K202264)Neocis, Inc.2020-12-04
Braces on Demand Bracket (K201940)Braces on Demand, Inc.2020-12-03
NobelProcera Zirconia Implant Bridge (K202452)Nobel Biocare AB2020-12-03
Magic UCLA Abutment System (K202418)Innobiosurg Co., Ltd.2020-12-03
Z5-TL (K201712)Z-Systems AG2020-12-01
Bright High Flow (K200155)Genoss Co., Ltd.2020-11-30
PRE-MILLED Abutment (K202269)Mit Global Co., Ltd.2020-11-25
Monet Curing Laser (K201904)CAO Group, Inc.2020-11-24
G-CEM ONE (K200798)GC America, Inc.2020-11-24
Somnos Anti-Snoring Mouth Guard (K201484)Koncept Innovators, LLC2020-11-23
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring (K202529)Prosomnus Sleep Technologies, Inc.2020-11-20
LC ResinCal PC (K202413)S&C Polymer Silicon- Und Composite Spezialitaten GmbH2020-11-20
FotoDent denture (K200580)Dreve Dentamid GmbH2020-11-19
S.I.N. Dental Implant System (K200992)S.I.N. - Sistema DE Implante Nacional S.A.2020-11-17
TiUltra Implants and Xeal Abutments (K202344)Nobel Biocare AB2020-11-16
Freeprint denture (K200461)Detax GmbH & Co. KG2020-11-16
Telio CAD Abutment Solutions- extra systems (K193193)Ivoclar Vivadent, AG2020-11-16
Kerecis Gingiva Graft (K192612)Kerecis Limited2020-11-13
Ceramir Restore QuikCap (K201937)Doxa Dental AB2020-11-13
TP Orthodontics Clear Aligner System (K193385)Tp Orthodontics, Inc.2020-11-12
JTK Dental Implant System (K183044)Jiangyin Jintech Biotech Co., Ltd.2020-11-10
Concinnity Aligners (K200005)Drake Precision Dental Laboratory, Inc.2020-11-09
Clio Prime and Clio Pedo (K202664)Sota Precision Optics, Inc. Dba Sota Imaging2020-11-06
BioMin Restore Plus (K200077)Dr. Collins, Inc.2020-11-06
GR-17 Resin System (K201827)Pro3Dure Medical GmbH2020-11-05
DigiGuide System (K193499)Protomed, Inc.2020-11-04
PMMA Block (K201683)Huge Dental Material Co., Ltd.2020-11-03
HCG Zirconia Ceramic Block (K193090)Hocheng Corporation2020-10-29
MedCAD® AccuPlan® System (K192282)Medcad2020-10-29
Bright Bond Universal (K200153)Genoss Co., Ltd.2020-10-28
TIB Abutment System (K193084)Southern Implants (Pty), Ltd.2020-10-27
General Cutting Contra Handpiece (K202960)Nakanishi, Inc.2020-10-27
Bright Low Flow (K200156)Genoss Co., Ltd.2020-10-27
FREEPRINT temp (K200273)Detax GmbH & Co. KG2020-10-27
DIOnavi-Denture (K193623)Dio Corporation2020-10-22
MS Lide Implant Systems (K181477)Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.2020-10-20
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100)Neocis, Inc.2020-10-19
MINICONE Implant (K200906)Medentika GmbH2020-10-16
Z5-BL (K200386)Z-Systems AG2020-10-14
Luce Ceramic Bracket (K201038)Luce Castle Co., Ltd.2020-10-09
Impression Material (K201483)Zhengzhou Huaer Electro Optics Technology Co., Ltd.2020-10-08
ScanX Edge (K202633)Dürr Dental SE2020-10-07
URIS OMNI Narrow System & Prosthetic (K200817)Truabutment, Inc.2020-10-07
Abutment Design (K200100)3Shape A/S2020-10-07
Membrane Screws and Membrane Tacks (K201561)Neoss Limited2020-10-05
BZF-29 (K200682)GC America, Inc.2020-10-02
OssGuide (K200623)Sk Bioland Co., Ltd.2020-10-02
Encore System (K201238)Siesta Medical, Inc.2020-10-02
Slow Wave DS8 (K191320)Slow Wave, Inc.2020-10-02
OsOpia Synthetic Bone Void Filler (K201546)Revisios BV2020-10-02
Dual Cure Resin Cement (K201790)Rizhao Huge Biomaterials Company, Ltd.2020-09-29
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants (K193401)Altatec GmbH2020-09-29
Transcend (K201795)Ultradent Product, Inc.2020-09-28
Eon Aligner (K202685)Eon Dental Jordan, LLC2020-09-28
Light Cure Dental Adhesive (K201787)Rizhao Huge Biomaterials Company, Ltd.2020-09-25
Honorst Implant System (K202039)Medimecca Co., Ltd.2020-09-25
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