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Dental

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

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RecordFirmDate
Quantum LB (K161684)Reliance Orthodontic Products, Inc.2016-10-06
DMi Dental Implant System (K160060)Dmi Innovative Medical Technology , Ltd.2016-10-03
TempoCem Clear (K160443)Dmg USA, Inc.2016-09-30
i-Sil (K161774)Spident Co., Ltd.2016-09-30
CreoDent Solidex Custom Abutment (K160436)Creodent Prosthetics, Ltd.2016-09-29
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head (K160410)Dental Savings Club2016-09-29
PINK CAD/CAM disc (K153546)Polident D.O.O., Dental Products Industry2016-09-28
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (K160825)Dentsply Sirona2016-09-27
CDB Self Ligating Bracket 8F (K160957)Cdb Corporation2016-09-27
TPH Spectra+ Universal Composite Restorative (K162107)Dentsply Sirona2016-09-27
O2VENT T (K161832)Oventus Manufacturing Pty, Ltd.2016-09-23
ATLANTIS ISUS Implant Suprastructures (K160207)Dentsply International, Inc.2016-09-21
SomnoDent ALPHA (K162306)Somnomed, Inc.2016-09-20
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, (K160262)Institut Straumann AG2016-09-16
Neodent Implant System - Titanium Base for CEREC (K160964)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2016-09-16
Luminesse Shaded Zirconia SZ (K152023)Talladium, Inc.2016-09-15
Dentium Implantium & SuperLine Prosthetics (K160828)Dentium Co., Ltd.2016-09-15
Provicol QM Plus (K161630)Voco GmbH2016-09-15
CAM Titanium Blanks (K160784)Altatec GmbH2016-09-14
OSTEON III (K153676)Genoss Co., Ltd.2016-09-14
Initial LiSi Block (K153130)GC America, Inc.2016-09-13
Pavati Z40.2 Zirconia (K160867)Ccri, Inc.2016-09-12
Implance Dental Implant System, Implance Dental Abutment System (K160221)Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.2016-09-12
All-Bond Universal w/BAC (not finalized) (K161051)Bisco, Inc.2016-09-09
Navident (K161406)Claronav, Inc.2016-09-08
BBX1, BBX2, BBX1MO, BBX1MC (K142846)Globaldental, Inc.2016-09-08
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493)Salvin Dental Specialties2016-09-08
3Shape Abutment Designer Software (K151455)3Shape A/S2016-09-06
JET SET 4 DENTURE REPAIR RESIN (K152981)Lang Dental Manufacturing Company, Inc.2016-09-02
XP202 (K161922)3M Deutschland GmbH2016-09-01
Noiselezz (K160531)Firma Ingemarsson2016-09-01
EzRay Air (Model VEX-P300) (K161063)VATECH Co., Ltd.2016-09-01
MTA2.2 MATERIAL (K161239)Avalon Biomed, Inc.2016-09-01
MTA Repair HP (K151047)Angelus Industria DE Productos Odontologicos2016-08-31
ATLANTIS Abutment for HIOSSEN ET implant (K160626)Dentsply Sirona2016-08-29
GPS Angled Abutment (K153509)Implant Direct Sybron Manufacturing, LLC2016-08-26
CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830)Oracrew2016-08-26
LUNA DENTAL IMPLANT SYSTEM (K160106)Shinhung Mst Co., Ltd.2016-08-26
ATLANTIS Abutment for CONELOG implant (K161030)Dentsply Sirona2016-08-26
ORTHODONTIC CERAMIC BRACKETS 1.1 (K160615)Tomy, Inc.2016-08-26
KATANA AVENCIA Block (K153476)Kuraray Noritake Dental, Inc.2016-08-23
Premium Plus C01/C02 LED Curing Light (K153514)Premium Plus International Limited2016-08-22
Oral Surgery System and Accessories (K152125)Bonart Co., Ltd.2016-08-15
EMS-200 (K153285)Meta Systems Co., Ltd.2016-08-12
CELTRA Press (K161269)Dentsply Sirona2016-08-12
OT EQUATOR (K160382)Rhein'83 Srl2016-08-11
TAP 3, TAP 1 (K160239)Airway Management, Inc.2016-08-10
SnoreRx (K153200)Apnea Sciences Corporation2016-08-09
ArgenIS Titanium Abutments (K160248)Argen Corporation2016-08-05
Image Fast Set, Image Regular Set (K160097)Sybron Dental Specialties2016-08-05
Burn-out Cylinder and Angled Screw Abutments (K160483)Dentium Co., Ltd.2016-08-05
OSSIX PLUS (K160281)Datum Dental, Ltd.2016-08-04
OSSIX VOLUMAX (K153549)Datum Dental, Ltd.2016-08-04
CAPO BULK FILL (K152471)Schuetz Dental GmbH2016-08-04
IMMEDIATELOAD Dental Implant System (K151757)Immediateload S.A.2016-08-03
IonoStar Plus (K160774)Voco GmbH2016-08-03
A-Oss (K151542)Hiossen, Inc.2016-08-03
Clip Flow (K153493)Voco GmbH2016-07-29
TheraCem (K161256)Bisco, Inc.2016-07-29
Zeramex P6 Dental Implant System (K152385)Dentalpoint AG2016-07-27
BEAUTIFIL II LS (K160596)Shofu Dental Corporation2016-07-27
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (K153067)Sybron Dental Specialties2016-07-27
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K160367)Nissin-Metec China Co., Ltd.2016-07-27
NobelProcera HT ML FCZ Implant Bridge and Framework (K160158)Nobel Biocare AB2016-07-25
ST Internal Fixture System (K152787)T-Plus Implant Tech. Co., Ltd.2016-07-22
ET III Bio-SA Fixture System (K151626)Hiossen, Inc.2016-07-21
rainbow LS Block (K160144)Genoss Co., Ltd.2016-07-21
SHOFU Enamel Conditioner (K160086)Shofu Dental Corporation2016-07-21
BioHPP - breCAM.BioHPP (K152113)Bredent GmbH & Co. KG2016-07-21
NR Line Implant System (K153268)Dentium Co., Ltd.2016-07-20
CAD/CAMouflage Milling Bock (K160425)Prismatik Dentalcraft, Inc.2016-07-15
ShefaBone SCPC Resorbable Bone Graft (K153230)The Implantech Inc./Shefabone2016-07-14
Amber Mill Series and Amber Press Series (K160102)Hass Corp.2016-07-14
VALO Grand (K160551)Ultradent Products, Inc.2016-07-13
Gradia Plus (K153325)GC America, Inc.2016-07-12
Apinator (K160123)Allen J. Moses, Dds, Ltd.2016-07-12
AcceleDent Aura (K153048)Orthoaccel Technologies, Inc.2016-07-08
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (K153231)GC America, Inc.2016-07-06
Identic and KromaFaze Alginate Dental Impression Materials (K160441)Kerr Corporation2016-06-30
Initial LiSi Press (K153136)GC America, Inc.2016-06-30
VITA ENAMIC Implant Solutions (IS) (K153645)Vita Zahnfabrik H.Rauter GmbH Co.2016-06-30
Admira Fusion Flow (K153177)Voco GmbH2016-06-30
LED Curing Light GT-2000 (K153078)Monitex Industrial Co., Ltd.2016-06-28
CELALUX 3 (K153018)Voco GmbH2016-06-23
s-Clean Tapered II RBM Implant System (K160213)Dentis Co., Ltd.2016-06-21
BI IMAGE-X EVOLUTION (K160458)Radiotecnologia Industrial S.A. DE C.V.2016-06-20
Dentivera Milling Disc (K160498)Dental Solutions, LLC2016-06-15
DSM Biomedical Porcine Pericardium Dental Membrane (K160474)Kensey Nash Corporation Dba Dsm Biomedical2016-06-07
A Plus Internal Fixture System (K152786)T-Plus Implant Tech. Co., Ltd.2016-06-07
NobelProcera HT ML Full Contour Zirconia Crown (K153534)Nobel Biocare AB2016-06-06
ORAL BOND (K142130)Steiner Laboratories2016-06-06
Sonendo GentleWave System (K160905)Sonendo, Inc.2016-06-03
VARIOunite (K160244)Thommen Medical AG2016-06-02
NobelSpeedy Groovy (K160119)Nobel Biocare AB2016-06-02
NobelDesign Software (K153036)Nobel Biocare AB2016-06-02
Anker II Dental Implant System (K152576)Alliance Global Technology Co., Ltd.2016-06-02
CEREC SpeedGlaze (K160099)Sirona Dental Systems GmbH2016-06-02
DCI Edge Dental Chair with Operative Unit (K151987)Dci2016-06-01
NoCord (K152826)Centrix, Inc.2016-05-27
BIJOU Orthodontic Ceramic Bracket (K152167)World Bio Tech Co., Ltd.2016-05-27
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