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Dental

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

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RecordFirmDate
TS Abutment System (K233194)Osstem Implant Co., Ltd.2024-02-20
Oral Matrix (K231513)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2024-02-16
airVata™ (K240427)Gelb Practice Solutions, Inc.2024-02-14
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (K233954)B&E Korea Co., Ltd.2024-02-13
T-FIT (K231913)Techwin Co., Ltd.2024-02-08
XVbeam2000 (K233914)Shenzhen Xpectvision Technology Co., Ltd.2024-02-08
One-Fil (K232182)Mediclus Co., Ltd.2024-01-26
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (K233208)Nobel Biocare AB2024-01-24
Chemo Mouthpiece (K232917)Chemo Mouthpiece, LLC2024-01-23
Dental Glass Ceramics (K232673)Chengdu Besmile Medical Technology Co., Ltd.2024-01-23
Endoform Dental Membrane (K231305)Aroa Biosurgery , Ltd.2024-01-23
Dental Porcelain Powder (K232676)Chengdu Besmile Medical Technology Co., Ltd.2024-01-23
MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw (K233450)Megagen Implant Co., Ltd.2024-01-22
S-Plant Dental Implant System (K221866)Newton Implant Systems, Inc.2024-01-18
Aniti-Snore Mouthguard+ (K231138)Oscimed SA2024-01-16
Stryker Facial iD System (K232350)Stryker Craniomaxillofacial2024-01-13
Ti Link Abutment (K232170)Izenimplant Co., Ltd.2024-01-12
Zirconia Block (K233125)Hangzhou Ivista Medical Devices Co., Ltd.2024-01-12
Clevaligner Software (V1.0.0) (K233616)Clevaligner, Ltd.2024-01-11
DESS Dental Smart Solutions (K233316)Terrats Medical SL2024-01-05
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (K231263)Prevest Denpro Limited2024-01-05
Anthogyr FlexiBase® titanium bases for Axiom® BL (K231072)Anthogyr2024-01-04
Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) (K233395)Alliage S/A Industrias Médico Odontológica2024-01-03
URIS Smart Path Implant System & Prosthetic (K230438)Truabutment, Inc.2023-12-29
UniFit Dental Implant System (K223714)Adin Dental Implant Systems , Ltd.2023-12-29
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) (K231055)De Götzen S.R.L.2023-12-28
TopCEM Dual Cure Resin Cement (K233082)Rizhao Huge Biomaterials Company, Ltd.2023-12-22
3M™ Transbond™ Orthodontic Adhesive (K234043)3M Unitek Orthodontic Products2023-12-22
Elos Accurate Customized Abutment (K231307)Elos Medtech Pinol A/S2023-12-21
Dental Glass Ceramics (K233016)Shenzhen Yurucheng Dental Materials Co., Ltd.2023-12-21
INNO SLA Submerged Hybrid Ti-Base System (K231411)Cowellmedi Co., Ltd.2023-12-20
Digital image scanner of dental (K231660)Jiangsu Dynamic Medical Technology Co., Ltd.2023-12-20
Angled Abutment (K232560)Arum Dentistry Co., Ltd.2023-12-19
ZENEX Implant System_Short (K233163)Izenimplant Co., Ltd.2023-12-19
S-Plant Dental Implant System (K231429)Idis Co., Ltd.2023-12-18
Invisalign Palatal Expander System (K232887)Align Technology, Inc.2023-12-15
C50 (K223470)Sopro2023-12-14
SaliPen (K232063)Saliwell , Ltd.2023-12-13
Neodent Implant System - Zirconia Implant System (K231803)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-12-13
CLEARFIL Universal Bond Quick 2 (K231039)Kuraray Noritake Dental, Inc.2023-12-13
EDS Calculus Softener TURBO CR (K223340)Essential Dental Systems, Inc.2023-12-11
BTI Interna Prosthetic Components (K232750)B.T.I. Biotechnology Institute, Sl.2023-12-08
Lumina-PTFE Titanium (K221851)Criteria Industria E Comercio DE Produtos Medicinais2023-12-08
DVAS (DVAS-M, DVAS-W) (K232085)Genoray Co., Ltd.2023-12-08
ARi ExCon Implant System (K231967)Megagen Implant Co., Ltd.2023-12-07
S.I.N. Dental Implant System (K231127)S.I.N. - Sistema DE Implante Nacional S.A.2023-12-07
SS Abutment System (K232220)Osstem Implant Co., Ltd.2023-12-05
AlignerFlow LC (K231817)Voco GmbH2023-12-01
Single Platform SP1 Implant System (K232418)Southern Implants (Pty), Ltd.2023-12-01
Dental Glass Ceramics Blocks (K232438)Aibodent Biotechnology Co., Ltd.2023-12-01
C.A.R.E. Appliance (DNA, mRNA, mmRNA) (K230947)Vivos Therapeutics, Inc.2023-11-28
N1 (K232012)Osstem Implant Co., Ltd.2023-11-28
PF Keep; Cad Cam Keep Block (K233171)Clemde SA DE CV2023-11-27
NemoCast (K232549)Software Nemotec S.L.2023-11-21
Ultrasonic Scaler Tips (K230641)Guilin Refine Medical Instrument Co., Ltd.2023-11-21
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor (K233053)Dental Imaging Technologies Corporation2023-11-21
Meta G UCLA Abutment (K232546)Cowellmedi Co., Ltd.2023-11-21
Multi-Unit DAS System (K231559)Talladium España, SL2023-11-17
Curing Light, Model: MaxCure 9 (K223414)Guilin Refine Medical Instrument Co., Ltd.2023-11-15
saremco print BRIDGETEC (K232050)Saremco Dental AG2023-11-14
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) (K233434)Prismatik Dentalcraft, Inc.2023-11-14
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems (K231097)Prismatik Dentalcraft, Inc.2023-11-14
Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810)Micro-Nx Co., Ltd.2023-11-09
VarseoSmile TriniQ (K233596)Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2023-11-09
Fibercure (K232076)Lumendo AG2023-11-02
BASE290 LED Curing Light (K233518)Handpiece Headquarters2023-11-02
TERA HARZ II (K233502)Graphy, Inc.2023-11-01
Neodent Implant System - GM Zygomatic Implant System (K232099)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-10-31
AOT & T-L Abutment (K231874)Truabutment, Inc.2023-10-30
BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge (K232393)Proedge Dental Products, Inc.2023-10-27
Centrix FluoroSilver Silver Diamine Fluoride 38% (K222459)Centrix, Inc.2023-10-27
SIMDA abutment (K232271)Simda Co., Ltd.2023-10-26
UNIdental Symphony Implant System (K221315)Unidental Co., Ltd.2023-10-25
TuxDeluxe (Size 1 6100B, Size 2 6101B) (K232552)Tuxedo Imaging, LLC2023-10-20
Digital Wireless Intraoral X-Ray Sensor (K230998)Iray Imaging Technology (Haining) Limited2023-10-20
Lucitone Digital Print Denture System (K231578)Dentsply Sirona2023-10-20
NextDent Base (K231388)Vertex-Dental B.V.2023-10-20
Byte Aligner System (K230199)Dentsply Sirona, Inc.2023-10-18
INNO SLA Submerged Narrow Implant System (K231395)Cowellmedi Co., Ltd.2023-10-18
Dynamic TiBase (K232151)Talladium España, SL2023-10-17
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (K230104)Anthogyr2023-10-16
Titan Dental Design (K232429)Clearadvance, LLC2023-10-13
S1 (K231672)Medpark Co., Ltd.2023-10-13
MRI compatibility for existing BioHorizons dental implants and abutments (K223697)BioHorizons Implant Systems, Inc.2023-10-13
MegaGen Dental Implant Systems Portfolio - MR Conditional (K230618)Megagen Implant Co., Ltd.2023-10-11
IPD Dental Implant Abutments (K231413)Implant Protesis Dental 2004, S.L.2023-10-10
WeSensor (K230916)Picopack, Inc.2023-10-10
THE Cover (K230091)Purgo Biologics, Inc.2023-10-06
OsteoCentric Dental Implant System (K230242)OsteoCentric Technologies2023-10-05
tmCMF Solution (K231520)Techmah Cmf2023-10-02
Warantec Custom Abutment (K221972)Warantec Co., Ltd.2023-10-02
3M™ Clarity™Aligners with Quick Attachments (K233257)3M Company, Unitek Orthodontic Products2023-09-29
CeraPutty (K232299)Meta Biomed Co., Ltd.2023-09-29
BeautiLink SA (K233161)Shofu Dental Corporation2023-09-28
EZSensor XHD (K232255)Qpix Solutions, Inc.2023-09-27
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems (K223496)Prismatik Dentalcraft, Inc.2023-09-26
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (K230398)Medcad2023-09-26
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233)Align Technology, Inc.2023-09-26
Osstem Implant System (K222778)Osstem Implant Co., Ltd.2023-09-23
DX. Bond V Dental Bonding Adhesive (K232978)Sino-Dentex Co., Ltd.2023-09-22
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