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Dental

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

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RecordFirmDate
SMARTmatic (K163239)Kaltenbach & Voigt GmbH2017-03-17
RnD TE and RnD SE (K161077)Apex Dental Materials, Inc.2017-03-17
Noris Medical MBI-2mm Dental Implant System (K162308)Noris Medical , Ltd.2017-03-17
MAZIC Duro (K163346)Vericom Co., Ltd.2017-03-17
Multi-unit Abutment Plus (K161416)Nobel Biocare AB2017-03-16
NobelZygoma 0° (K161598)Nobel Biocare AB2017-03-14
TotalC-Ram (K162960)Itena Clinical2017-03-14
mollosil plus (K162654)Detax GmbH & Co. KG2017-03-13
JAZZ SOLO Sensor (K163224)Jazz Imaging, LLC2017-03-09
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (K162890)Straumann USA, LLC2017-03-08
Dentca Denture Base II (K162044)Dentca, Inc.2017-03-03
Glass Ionomer Cement (K160345)Shandong Huge Dental Material Corporation2017-03-03
n!ce Glass Ceramic Blocks for Amann Girrbach (K170420)Institut Straumann AG2017-03-02
Apex Dental Sensors (K163282)Masterlink, LLC2017-02-28
On1 Concept (K161655)Nobel Biocare AB2017-02-28
Renamel NANO +plus (K163480)Cosmedent, Inc.2017-02-24
Dental Implants OKTAGON Tissue Level and Bone Level (K162073)Hager& Meisinger GmbH2017-02-24
Cercon (K162888)Dentsply Sirona2017-02-24
Air-Powered Handpieces and Handpiece Attachments (K162926)W&H Dentalwerk Burmoos GmbH2017-02-23
Dual Top Screw System (K161335)Jeil Medical Corporation2017-02-23
MEG-TORQ (K161500)Micro-Nx Co., Ltd.2017-02-22
ELECTROmatic (K163317)Kaltenbach & Voigt Gmgh2017-02-21
UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure (K161987)Dio Corporation2017-02-21
GenNarino (K160799)Saliwell , Ltd.2017-02-17
IBS Implant System II (K162099)Innobiosurg Co., Ltd.2017-02-15
JUVORA Dental Disc, Ceramill PEEK by JUVORA (K160918)Juvora2017-02-13
XSmart iQ (K161213)Dentsply Sirona2017-02-10
Porcine Anorganic Bone Mineral in Delivery Applicator (K162158)Collagen Matrix, Inc.2017-02-09
Fuselier Intraoral Nighttime Device (FIND) (K161980)Fuselier Enterprises, LLC2017-02-07
3M Protemp Cement Temporary Dental Cement (K170330)3M Company2017-02-06
MTM Clear Aligner (K163155)Dentsply Sirona2017-02-03
priti multidisc ZrO2 High Translucent (K161025)Pritidenta GmbH2017-02-03
US SA Implant System (K161103)Osstem Implant Co., Ltd.2017-02-02
ET Hybrid Abutment (K162390)Hiossen, Inc.2017-01-30
3M Clear Tray Aligner (K163689)3M Unitek Corporation2017-01-27
Zmaxx T Series (K161219)Maxx Digm, Inc.2017-01-26
EzRay Air W (K163705)VATECH Co., Ltd.2017-01-24
GMI Frontier Dental Implant System (K161593)Ilerimplant S.L2017-01-19
LEDEX WL070+ (K163605)Dentmate Technology Co. , Ltd.2017-01-19
Titan 3 Low Speed Angle Attachments (K162397)Dentalez, Inc.2017-01-19
RX DC (K163519)Cefla S.C.2017-01-13
SuperLine (K160965)Dentium Co., Ltd.2017-01-13
DynaMatrix/Dynamatrix Plus (K161762)Cook Biotech Incorporated2017-01-13
Tooth Shade Resin Material (K162323)Liaoning Upcera Co., Ltd.2017-01-12
CERAMAGE UP (K162261)Shofu Dental Corporation2017-01-11
Dentalis Bio Solution Implants (K161281)Dentalis Bio Solution Implants, LLC2017-01-11
Neo GBR System (K160991)Neobiotech Co., Ltd.2017-01-10
Chaorum Implant System (K160536)Medimecca Co., Ltd.2017-01-05
Neocis Guidance System (K161399)Neocis, Inc.2016-12-22
Y-MIC (K161639)Micron Corporation2016-12-22
L- OVC (K162677)Rhondium, Ltd.2016-12-21
EndoVac Pure (K162436)Kerr Corporation2016-12-21
Orthodontic Screw (K161197)Osstem Implant Co., Ltd.2016-12-21
Dentium CAD/CAM Abutments (K161713)Dentium Co., Ltd.2016-12-16
IPS e.max® Press Abutment Solutions for Viteo Base Ti (K160798)Ivoclar Vivadent, AG2016-12-15
BluePro (K162192)Bluesom2016-12-15
Ritter Dental Implant System (K160475)Ritter Implants GmbH & Co. KG2016-12-14
Vanguard Dental Unit (K161734)Ritter Concept GmbH2016-12-09
ESTETICA Dental Treatment Unit and Accessories (K161488)Kaltenbach & Voigt GmbH2016-12-08
s-Clean OneQ-SL Narrow Implant System (K161244)Dentis Co., Ltd.2016-12-07
PREMIUM Implant Systems SHELTA Implant Systems (K162004)Sweden & Martina S.P.A.2016-12-05
Transfer & Angled Abutment (K153015)Osstem Implant Co., Ltd.2016-12-05
V-varnish Premium (K160377)Vericom Co., Ltd.2016-12-02
Internal Distraction - Sterile (K161470)KLS Martin L.P.2016-12-01
Zeramex P6 Dental Implant System (K163043)Dentalpoint AG2016-11-30
Filtek One Bulk Fill Restorative (K163207)3M Company2016-11-28
Carriere Motion Clear Class II (K160720)Ortho Organizers, Inc.2016-11-28
W&H Implantmed SI-1015 incl. Accessories (K161957)W&H Dentalwerk Burmoos GmbH2016-11-23
NobelProcera HT ML FCZ Bridge (K162043)Nobel Biocare AB2016-11-22
Temporary Snap Abutment (K161435)Nobel Biocare AB2016-11-22
HC Primer (K161891)Shofu Dental Corporation2016-11-21
Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC (K160132)Hager& Meisinger GmbH2016-11-21
RODO Abutment System (K160786)Rodo Medical, Inc.2016-11-21
CAD/CAMouflage Milling Block (K162537)Prismatik Dentalcraft, Inc.2016-11-16
DuoCem (K160800)Coltene/Whaledent AG2016-11-16
Charisma (K160049)Heraeus Kulzer, LLC (Mitsui Chemicals Group)2016-11-15
rainbow Shine (K160079)Genoss Co., Ltd.2016-11-10
HYPNOSPAD (K152660)Somnics, Inc.2016-11-09
P1145 Dental Restorative (K162257)Kerr Corporation2016-11-07
MicrO2 OSA Device with Micro-Recorder (K161624)Microdental, Inc.2016-11-07
I View and Imagen Sensor (K162619)Trident S.R.L2016-11-04
Inclusive Abutments (K160979)Prismatik Dentalcraft, Inc.2016-11-04
SuniIQ Digital Radiography System (K162585)Suni Medical Imaging, Inc.2016-11-04
Vonflex S (K152615)Vericom Co., Ltd.2016-11-03
FONA Pan/Ceph (K161131)Fona S.R.L2016-11-03
Glass Ionomer Cement (Luting) (K161851)Shandong Huge Dental Material Corporation2016-10-31
Dental Implants and Abutments (K161497)Ditron Precision, Ltd.2016-10-28
Link Abutment for CEREC (K160519)Osstem Implant Co., Ltd.2016-10-28
ETIII SA Fixture System (O3.2mm) (K153332)Hiossen, Inc.2016-10-27
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack (K161042)Kuraray Noritake Dental, Inc.2016-10-25
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow (K151399)Schutz Dental GmbH2016-10-24
KJ Mini Implant System (K151970)Kj Meditech Co., Ltd.2016-10-21
OPTIMUS CMF SYSTEM (K160363)Osteonic Co., Ltd.2016-10-20
ADAMANT ZIRCONIA DISC (K160203)Adamant Co., Ltd.2016-10-19
Premier Sealant (K161580)Premier Dental Company Products2016-10-18
OSSTEM Implant System (K161604)Osstem Implant Co., Ltd.2016-10-17
BracePaste Adhesive (K160782)American Orthodontics2016-10-14
IH Implant System (K153521)Sewonmedix, Inc.2016-10-14
Straumann Sterile Healing Solution (K161677)Institut Straumann AG2016-10-07
Pour Acrylic (K161330)Dentsply Sirona2016-10-06
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