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Dental

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

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RecordFirmDate
Implanter incl. Accessories (K211358)Guilin Woodpecker Medical Instrument Co., Ltd.2022-11-21
Vista BC Sealer (K221811)Inter-Med, Inc.2022-11-21
FX Contra (K222518)Nakanishi, Inc.2022-11-17
Dentca Base Premium, Dentca Base Hi-Impact (K220042)Dentca, Inc.2022-11-17
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece (K212910)Shenzhen Carejoy Technology Co., Ltd.2022-11-17
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (K220841)Dentsply Sirona2022-11-16
OmniTaper EV Dental Implants, DS Implants abutments with EV connection (K221094)Dentsply Sirona2022-11-16
Zirconia Block (K222520)Yilink (Tianjin) Biotechnology Co., Ltd.2022-11-14
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (K220562)Megagen Implant Co., Ltd.2022-11-10
SprintRay High Impact Denture Base (K221678)Sprintray, Inc.2022-11-10
SNOR LOCK (K222475)Solbaro Co., Ltd.2022-11-10
Tandry CMF Plate System (K220360)Microware Precision Co., Ltd.2022-11-10
Universal CMF System (K221855)Stryker Leibinger GmbH & Co KG2022-11-09
Zaga Zygomatic System (K222497)Southern Implants (Pty), Ltd.2022-11-09
Smooth Drive contra angle and straight handpieces (K220874)Lares Research2022-11-07
Lotus Prophy Angle (K220346)Ajk Engineering, Inc.2022-11-07
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741)Hdi, Inc.2022-11-07
Yomi Robotic System (K222049)Neocis, Inc.2022-11-04
Tera Harz Clear (K223355)Graphy, Inc.2022-11-03
Stela Capsule System (K222583)Sdi Limited2022-10-28
Stela Automix System (K222581)Sdi Limited2022-10-28
S.I.N. Dental Implant System (K222231)S.I.N. - Sistema DE Implante Nacional S.A.2022-10-27
CUSTMBITE Snoring System (K221322)Dental Choice Holdings, LLC2022-10-27
DESS Dental Smart Solutions (K222288)Terrats Medical SL2022-10-27
Preat Abutments (K220823)Preat Corporation2022-10-26
EzRay Air 2 Wall (Model: VEX-S350W) (K223058)VATECH Co., Ltd.2022-10-26
DESS Dental Smart Solutions (K222269)Terrats Medical SL2022-10-26
Soft Palate Elevator (K222127)The Tmj Clinic PC2022-10-24
IPD Dental Implant Abutments (K222215)Implant Protesis Dental 2004, S.L.2022-10-21
BTI Interna Dental Implant System UnicCa - Prosthetic Components (K213106)B.T.I. Biotechnology Institute, Sl.2022-10-20
Infinity Pro, Logic, Quality, Sprint (K213742)Olsen Indústria E Comércio S.A.2022-10-19
Proximerge 2 Dental Implant System (K211409)Quadric Biomed, LLC2022-10-19
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (K214054)Tp Orthodontics, Inc.2022-10-14
The Cooral System (DEN210027)Braincool AB2022-10-14
CREOKORREKT Aligners (K211427)Creodent Prosthetics, Ltd.2022-10-13
IM/ST Fixture System (K212702)Guilin Fiteeth Medical Instrument Co., Ltd.2022-10-13
PiezoImplant System (K211872)Rex Implants, Inc.2022-10-12
TrusFIL-Flow Flowable Composite Restorative (K221510)Rizhao Huge Biomaterials Company, Ltd.2022-10-12
Renamel® Microhybrid ;Renamel® Flowable Microhybrid (K222435)Cosmedent, Inc.2022-10-11
Mico One Orthodontic Screw (K202163)Ze Fang Technology Co., Ltd.2022-10-07
Nuvola (K222418)Gruppo Europeo Ortodonzia Srl2022-10-07
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring (K221889)Prosomnus Sleep Technologies2022-10-06
Perfit FS Dental Zirconia Fully Sintered Block (K222686)Vatech Acucera, Inc.2022-10-06
ClearCorrect System (K220140)Clearcorrect, LLC2022-10-05
EmbedMed (K220366)3D Lifeprints UK , Ltd.2022-09-30
Kerecis Oral (K213904)Kerecis2022-09-30
Dental Air Polishing Handpiece (K221548)Guilin Woodpecker Medical Instrument Co., Ltd.2022-09-28
Dental Implantation Systems, Dental Electrical Motors (K220831)Foshan Coxo Medical Instrument Co., Ltd.2022-09-27
A.B. Dental Devices Dental Implants System (K202144)A.B. Dental Device , Ltd.2022-09-23
DENU Composite Resin, DENU Flow Resin (K213339)Hdi, Inc.2022-09-23
FREEPRINT crown (K222877)Detax GmbH2022-09-23
Esthetic Colorant (K220369)Kuraray Noritake Dental, Inc.2022-09-23
GlasIonomer FX ULTRA (K222253)Shofu Dental Corporation2022-09-22
EQ-M (K210475)Meta Systems Co., Ltd.2022-09-21
V-Print dentbase (K220236)Voco GmbH2022-09-21
Pro M Class (K213897)Saeyang Microtech Co., Ltd.2022-09-19
NB 1 SA Implant System (K222131)Arum Dentistry Co., Ltd.2022-09-19
Esthetic Abutments Nobel Biocare N1 (K220339)Nobel Biocare Services AG2022-09-16
LEDEX (K221194)Dentmate Technology Co. , Ltd.2022-09-16
L1P-1F (TRIOS 5) (K221249)3Shape TRIOS A/S2022-09-16
Dynamic TiBase (K221966)Talladium Espana, SL2022-09-15
SprintRay Denture Base (K220979)Sprintray, Inc.2022-09-14
LightForce Orthodontic System (K222764)Lightforce Orthodontics2022-09-14
TSX Implants (K220978)Biomet 3i, LLC2022-09-14
Phosphoric Acid Etching Gel (K221450)Rizhao Huge Biomaterials Company, Ltd.2022-09-12
AMBARINO High-Class (K222723)Creamed GmbH & Co. Produktions- Und Handels KG2022-09-09
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (K213244)Prevest Denpro Limited2022-09-09
Osstem Abutment System (K221684)Osstem Implant Co., Ltd.2022-09-08
Soundly Anti Snoring Device (K220330)Greystone Ip, Ltd.2022-09-08
Ultrasonic Endo Activation Device (Model:Actor I pro) (K213947)Changzhou Bomedent Medical Technology Co.,Ltd2022-09-08
Neodent Implant System - GM Narrow Implant System (K220251)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2022-09-06
Hybrid C70 (K220579)Digimed Co., Ltd.2022-09-01
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (K221255)Kerr Corporation2022-08-31
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (K221955)Realcloud Imaging Inc. Dba Realcloud Imaging2022-08-31
MyClearALIGN Dental Aligner System (K221475)Key Dental Technologies, LLC2022-08-31
Riva Cem Automix (K214118)Sdi Limited2022-08-30
SaliPen (K220618)Saliwell , Ltd.2022-08-30
FONA XDC (K222274)Fona S.R.L2022-08-23
Bifix Hybrid Abutment Cement (K220640)Voco GmbH2022-08-23
Bio-MEM Ti Reinforced Membrane (K210797)B&Medi Co., Ltd.2022-08-18
G-CAM (K220329)Graphenano Dental S.L.2022-08-16
Clear Aligner (K213026)Shenzhen Meiming Dentistry Technology Co., Ltd.2022-08-16
Arkligners (K220835)Arklign Laboratories2022-08-12
Denture Base Polymers (K220680)Shandong Huge Dental Material Corporation2022-08-12
KLS Martin IPS Distraction (K220050)KLS Martin L.P.2022-08-11
TERA HARZ DENTURE (K222414)Graphy, Inc.2022-08-11
OMF ASP System (K220648)Vha Dean2022-08-11
KDG Abutments (K221381)Keystone Dental, Inc.2022-08-10
BLT Dental Implant System (K212364)Bio Concept Co., Ltd.2022-08-10
IMICRYL Composite, Composite Flow Materials (K220077)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2022-08-09
NOVA RESIN dual cure, self adhesive resin cement (K213609)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2022-08-09
DenMat Glutaraldehyde Desensitizer (K222357)Denmat Holding, LLC2022-08-09
Dental Impression Material (K221668)Chemoment Materials Co.,Ltd2022-08-08
Root ZX3 (K213477)J. Morita USA, Inc.2022-08-03
BruxZir NOW (K220816)Prismatik Dentalcraft, Inc.2022-08-02
NobelProcera Zirconia N1 Base (K220048)Nobel Biocare Services AG2022-07-29
Dental Handpiece, Model CA160, CA160L, and CA500L (K220577)Micro-Nx Co., Ltd.2022-07-29
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K221242)Hunan Vsmile Biotechnology Co., Ltd.2022-07-29
BTI Interna Narrow/Plus Dental Implant System UnicCa (K211952)B.T.I. Biotechnology Institute, Sl.2022-07-21
KLS Martin Individual Patient Solutions (K210731)KLS-Martin L.P.2022-07-18
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