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Dental

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

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RecordFirmDate
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (K220179)Foshan Coxo Medical Instrument Co., Ltd.2023-09-22
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece (K231663)Innovative Health Technologies (Nz), Ltd.2023-09-18
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (K231827)B.T.I. Biotechnology Institute, Sl.2023-09-15
LW UCLA Abutment (K231235)Ossvis Co., Ltd.2023-09-15
Straumann® BLC and TLC Implants (K230108)Institut Straumann AG2023-09-14
LightForce Orthodontic System (K232827)Lightforce Orthodontics2023-09-14
LW Retraction Cap (K231079)Ossvis Co., Ltd.2023-09-14
GenX-CR (K232158)Genoray Co., Ltd.2023-09-13
Signum opaque F (K230644)Kulzer, LLC2023-09-07
Gradual Dental Zirconia Blank (K231687)Liaoning Upcera Co., Ltd.2023-09-07
Polibond (K232691)Zirkonzahn Srl2023-09-05
HyperLight Portable X-ray Unit (K232068)Changzhou Sifary Medical Technology Co., Ltd.2023-09-01
InnerView LC (K232657)Perimetrics, Inc.2023-09-01
Elos Accurate Hybrid Base (K230317)Elos Medtech Pinol A/S2023-09-01
TRIOCLEAR System (K231884)Modern Dental Laboratory (Dg) Co., Ltd.2023-09-01
ApneaRX Pro (K223901)Apnea Sciences Coporation2023-09-01
Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599)Stryker Leibinger GmbH & Co KG2023-08-24
ZENEX FreeMilling & CCM Cast Abutment (K231557)Izenimplant Co., Ltd.2023-08-24
Oneday Mini Implant System (K222946)Oneday Biotech Co., Ltd.2023-08-23
EVO 700 series high speed handpiece (K232243)Ttbio Corp.2023-08-23
ACR Screw System (K222245)Biomaterials Korea, Inc.2023-08-21
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (K232498)Ultradent Product, Inc.2023-08-18
Eco Abutment, Multiunit Abutment (K220253)Dio Corporation2023-08-18
InterCollagen® Guide (K223912)Sigmagraft, Inc.2023-08-17
Guided Surgery Kit (K231087)Implant Direct Sybron Manufacturing, LLC2023-08-16
Harvest Dental HD Gum Strip (K231389)Harvest Dental Products, LLC2023-08-16
Implant-One System (K231455)Implant Logistics, Inc.2023-08-15
DESS Dental Smart Solutions (K231434)Terrats Medical SL2023-08-14
Yomi Robotic System (K231018)Neocis, Inc.2023-08-14
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (K231696)Prevest Denpro Limited2023-08-11
LW Implant System (K223924)Ossvis Co., Ltd.2023-08-08
Stryker Resorbable Fixation System (K230733)Stryker Leibinger GmbH & Co KG2023-08-05
Dentis s-Clean Regular Abutment (K230126)Dentis Co., Ltd.2023-08-04
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (K223507)Good Doctors Co., Ltd.2023-08-04
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (K230873)Southern Implants (Pty), Ltd.2023-08-01
ZENEX Implant System_Narrow (K230630)Izenimplant Co., Ltd.2023-07-31
V-Print c&b temp (K231591)Voco GmbH2023-07-31
Bright MTA Sealer Plus (K231480)Genoss Co., Ltd.2023-07-28
Dia-Cem (K231552)DiaDent Group International2023-07-28
Enamel Coating Resin (K230455)Rizhao Huge Biomaterials Company, Ltd.2023-07-25
EsCom250 (K231523)Spident Co., Ltd.2023-07-24
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333)Kettenbach GmbH & Co. KG2023-07-24
TRUST (K221107)Rgorithm Korea2023-07-18
Bone Chamber Implant (K223339)Megagen Implant Co., Ltd.2023-07-18
Neodent Implant System - Zirconia Implant System (K222026)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2023-07-14
Bonafix TiBase (K221673)Zentek Medical, LLC2023-07-14
OnX Tough (K230445)Sprintray, Inc.2023-07-14
Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173)W&H Dentalwerk Buermoss GmbH2023-07-14
Portable X-ray System Model Ray98(P) (K231449)Ningbo Runyes Medical Instrument Co., Ltd.2023-07-13
Admira Fusion 5 (K230877)Voco GmbH2023-07-13
RADx Intraoral Appliance for Snoring and Sleep Apnea (K230532)Achaemenid, LLC2023-07-12
Dentis i-Clean System (K230307)Dentis Co., Ltd.2023-07-11
Endofill (K231387)Lumendo AG2023-07-10
Cleo (K232011)American Orthodontics2023-07-07
IH Implant System (K222707)Sewonmedix, Inc.2023-07-07
Lumos 3DX (K223780)3Dio2023-07-06
Dental Lithium Disilicate Glass-Ceramic (K230487)Fuzhou Rick Brown Biomaterials Co., Ltd.2023-07-03
NB Implant System (K230725)Arum Dentistry Co., Ltd.2023-07-01
Easy On Universal Glaze & Stain (K231264)Doctus Global2023-06-30
Z7 Zirconia Implant System (K221488)Z7, LLC2023-06-26
BR SLA Type Implant System (K222142)Biotem Co., Ltd.2023-06-24
DD medical polymers (PMMA) (K230410)Dental Direkt GmbH2023-06-23
Neodent Implant System - Helix Short Implant System (K223638)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2023-06-23
TECHFIT DISRP® System (K230276)Techfit Digital Surgery2023-06-23
Black Diamond (K222323)Elevate Oral Care, LLC2023-06-23
Straumann SLActive labeling changes (K223083)Institut Straumann AG2023-06-22
QuickRayPRO (K231202)Denterprise International, Inc.2023-06-22
SMARTbase Abutment System (K223535)Implant Direct Sybron Manufacturing, LLC2023-06-20
Perfit CL (K223029)Vatech Mcis Co., Ltd.2023-06-20
The iNAP One Sleep Therapy System (K220907)Somnics, Inc.2023-06-16
IR SLA Type Implant System (K222144)Biotem Co., Ltd.2023-06-14
iOrtho (K223518)Shanghai EA Medical Instruments Co., Ltd.2023-06-13
Clear Aligner (K223517)Wuxi EA Medical Instruments Technologies Limited.2023-06-13
BruxZir™ TintEFX Coloring Liquid (K231347)Prismatik Dentalcraft, Inc.2023-06-09
OrthoPulse 2.0E (OPi2E-100) (K230905)Biolux Technology GmbH2023-06-09
SNUCONE Tissue Level Implant System (K222792)Snucone Co., Ltd.2023-06-08
A-Line Advanced (K231635)Biocetec Co., Ltd.2023-06-06
DynaFlex Clear Brackets & Buttons (K230225)Dyna Flex2023-06-05
Stella (K221752)Shinhung Mst Co., Ltd.2023-06-04
Titanium Turbine (K230888)Nakanishi, Inc.2023-06-02
Harvest Conceal ZR Block Out (K222961)Harvest Dental Products, LLC2023-06-02
iRoot SP Plus (K231259)Innovative Bioceramix, Inc.2023-05-31
Soreal Press, Soreal CAD (K230259)Shenzhen Up3D Technology Co., Ltd.2023-05-25
Dentis s-Clean SQ-SL Narrow Implant System (K230246)Dentis Co., Ltd.2023-05-25
Genesis ACTIVE Implant System (K223814)Keystone Dental, Inc.2023-05-25
Dental Desensitizer (K222891)Guangzhou Beogene Biotech Co., Ltd.2023-05-25
s-Clean Link Abutment Narrow (K230523)Dentis Co., Ltd.2023-05-24
General Cutting Straight (K230106)Nakanishi, Inc.2023-05-24
SIMDA Abutment (K223663)Simda Co., Ltd.2023-05-24
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (K231464)3M Company, Unitek Orthodontic Products2023-05-22
Hi-Bond Universal (K230465)Mediclus Co., Ltd.2023-05-22
Endo Motor (K220829)Foshan Coxo Medical Instrument Co., Ltd.2023-05-18
BlueCheck™ Caries Detection & Monitoring (K222560)Incisive Technologies Pty, Ltd.2023-05-16
BruxZir™ Incisal Coloring Liquid (K230262)Prismatik Dentalcraft, Inc.2023-05-16
Combi Touch (K231391)Mectron S.P.A.2023-05-15
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (K222836)Institut Straumann AG2023-05-15
PMMA BLOCK (K223706)Huliang(Shanghai) Bio-Tech Co., Ltd.2023-05-12
IU Implant System Abutment (K221969)Warantec Co., Ltd.2023-05-12
Harvest Printable Resin (K222489)Harvest Dental Products, LLC2023-05-12
OpenTex (K222549)Purgo Biologics, Inc.2023-05-11
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