Atlas FDA

Dental

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

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RecordFirmDate
Straumann BoneCeramic (K201051)Institut Straumann AG2020-09-24
A-Silicone for Bite Registration (K201684)Shandong Huge Dental Material Corporation2020-09-24
IBS Implant System (K202479)Innobiosurg Co., Ltd.2020-09-23
DIA-ROOT BIO MTA (K200174)DiaDent Group International2020-09-18
ToothWave™ (DEN190039)Home Skinovations , Ltd.2020-09-17
Porcine Mineral Collagen Composite Moldable (K201859)Collagen Matrix, Inc.2020-09-11
Straight T Clear Dental Aligner (K201450)Straight T, Inc.2020-09-10
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (K201944)Synthes (USA) Products, LLC2020-09-10
DSM Biomedical Dental Bone Graft Plus (K193212)Dsm Biomedical2020-09-10
Structur CAD (K201090)Voco GmbH2020-09-09
iCTmotor (WL-1) (K193341)Dentium Co., Ltd.2020-09-04
Neodent Implant System - GM Helix Implants 7.0 (K201225)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-09-04
Diamond Digital Sleep Orthotic (DDSO) (K202499)Diamond Orthotic Laboratory2020-09-03
MIS Dental Implant System (K200102)Dentsply Sirona2020-09-03
LOCATOR R-Tx (K200827)Ivory Super Holdco, Incp.2020-09-02
EtchPro Etching Gel (K200462)Belport Company, Inc., Gingi-Pak2020-09-02
Bright Temporary C&B (K192830)Dmp Dental Industry S.A.2020-09-02
Simplant Digital Guide (K193405)Dentsply Sirona2020-09-02
Orthodontic Fixation Screw [Smart Anchor Miniscrew] (K191041)Gni Co., Ltd.2020-08-28
Oral-B iO Test Drive Power Brush Trial Program Kit (K200881)The Procter & Gamble Company2020-08-27
Magicore System (K201981)Innobiosurg Co., Ltd.2020-08-27
Nucleoss T6 Dental Implant System (K192062)Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST2020-08-27
Provicol QM Aesthetic (K201856)Voco GmbH2020-08-26
Dental Handpiece (K192809)Micro-Nx Co., Ltd.2020-08-25
U-Cem Premium & MAZIC Cem (K193260)Vericom Co., Ltd.2020-08-21
Straumann TLX Implant System (K200586)Institut Straumann AG2020-08-20
Straumann BLX Gold Abutments (K200597)Straumann USA, LLC (On Behalf of Institut Straumann Ag)2020-08-19
Sirona Dental CAD/CAM System with InLab Software (K200191)Dentsply Sirona2020-08-19
Omnichroma Flow (K193537)Tokuyama Dental Corporation2020-08-19
Keystone Dental XL Dental Implant System (K201334)Keystone Dental, Inc.2020-08-18
Coloring Liquid (K192723)Aidite (Qinhuangdao) Technology Co., Ltd.2020-08-18
BB Base 3D printing resin for denture base (K191591)Enlighten Materials Co., Ltd.2020-08-18
Cytrans Granules (K192597)GC America, Inc.2020-08-17
Sirona Dental CAD/CAM System with CEREC Chairside Software (K193408)Dentsply Sirona2020-08-16
BracePaste Band and Build LC (K202276)American Orthodontics2020-08-14
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (K201010)Nobio , Ltd.2020-08-14
LOOP LED Curing Light System (K200775)Garrison Dental Solutions, LLC2020-08-14
Orthocem, Ortho Bite (K192682)Dentscare Ltda2020-08-14
Straumann® Retentive System – Novaloc TiN Abutments (K193046)Institut Straumann AG2020-08-13
Disposable High Speed Air Turbine Handpiece (K193264)Ningbo Hpdove Dental Instruments Co., Ltd.2020-08-11
D-LUX+ (K200809)DiaDent Group International2020-08-07
MVP Aligner System (K193130)Mvp Aligners, LLC2020-08-07
P pro Crown & Bridge (K200039)Deltamed GmbH2020-07-31
Flex Fit (K190790)Dk Mungyo Corporation2020-07-31
I Do (K192294)I DO Biotech Co., Ltd.2020-07-31
BoniPlus Dental G-Mesh System (K182759)Montjade Engineering Co., Ltd.2020-07-29
Neocis Guidance System (NGS) with Patient Splints (K200805)Neocis, Inc.2020-07-28
Duranext Abutments (K200355)Elegant Dental Corp.2020-07-22
AUTOLIGN (K192847)Diorco Co., Ltd.2020-07-21
VITA LUMEX AC (K193434)Vita Zahnfabrik GmbH H Rauter & CO2020-07-21
Magicore II System (K201621)Innobiosurg Co., Ltd.2020-07-15
TRAUS SUS20 (K192561)Saeshin Precision Co., Ltd.2020-07-13
GC Temp Print (K193113)GC America, Inc.2020-07-09
VisCalor (K201307)Voco GmbH2020-07-08
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA (K200676)Zirkonzahn Srl2020-07-08
Dental Glass Ceramics Blocks (K192231)Aidite (Qinhuangdao) Technology Co., Ltd.2020-07-08
MIS Ti-base Abutment (K191152)Dentsply Sirona2020-07-06
IC-WHCD100 (Inspire) (K183471)Good Doctors Co., Ltd.2020-07-02
GC Fuji Triage EP (K193484)GC America, Inc.2020-07-02
Dental Electrical Motor iRoot Pro (K191276)Changzhou Bomedent Medical Technology Co.,Ltd2020-06-30
Surgical Drills (K200265)Implant Direct Sybron Manufacturing, LLC2020-06-30
JDentalCare Implant System JDIcon (K182081)Jdentalcare Srl2020-06-26
MSDI Dental Implants System (K191443)Medical Systems and Devices International , Ltd.2020-06-26
DIA-ROOT BIO Sealer (K200175)DiaDent Group International2020-06-25
FiteBac Antimicrobial Cavity Cleanser (K200614)Largent Health, LLC2020-06-25
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (K192221)Implant Direct Sybron Manufacturing, LLC2020-06-25
ULab Systems uDesign Software (K200772)Ulab Systems, Inc.2020-06-23
VarseoSmile Crown plus (K201668)Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2020-06-23
TruAbutment DS (K191913)Truabutment, Inc.2020-06-19
Fit & Brilliant Dental Implant System (K190637)F&B Technology Co., Ltd.2020-06-19
NUVO IF Implant System (K193234)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-06-18
BV Dental Implant System (K192274)Bio Concept Co., Ltd.2020-06-18
Yxoss CBR® (K192747)Reoss GmbH2020-06-17
BruxZir Steel (K200131)Prismatik Dentalcraft, Inc.2020-06-10
ImmersiveView Surgical Plan (IVSP®) (K181813)Immersivetouch2020-06-09
IBS Implant System II (K200753)Innobiosurg Co., Ltd.2020-06-09
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (K192033)Bennett Jacoby, Dds, Ms, Inc.2020-06-09
NemoCast (K193003)Software Nemotec S.L.2020-06-05
Dental Zirconia Blocks (K192262)De Corematrix Co., Ltd.2020-05-29
The iNAP One Sleep Therapy System (K193460)Somnice, Inc.2020-05-26
High-speed air turbine handpiece / Low-speed air turbine handpiece (K181691)Foshan Wenjian Medical Instrument Co., Ltd.2020-05-26
DiaPlus (K192392)DiaDent Group International2020-05-26
X-Guide® Surgical Navigation System (K200662)X-Nav Technologies, LLC2020-05-21
UF(II) Bar holder abutment (K193404)Dio Corporation2020-05-18
VarseoSmile Temp (K193553)Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG2020-05-18
VITA Ambria (K193436)Vita Zahnfabrik GmbH H Rauter & CO2020-05-14
S.I.N. Dental Implant System (K193096)S.I.N. - Sistema DE Implante Nacional S.A.2020-05-14
Purzir Dental Zirconia (K193055)3DBiocad2020-05-13
Arcad SmileStudio and Aligner System (K192244)Arcadlab2020-05-11
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (K200348)Neocis, Inc.2020-05-08
Custom Legacy and Custom InterActive Titanium Abutments (K192218)Implant Direct Sybron Manufacturing, LLC2020-05-08
ZAGA Zygomatic System (K192651)Southern Implants (Pty), Ltd.2020-05-07
CharmFil (K193496)Dentkist, Inc.2020-05-06
Aerodentis System (K192069)Dror Orthodesign2020-05-06
Lascod Impression Materials (K201184)Lascod Spa2020-05-05
AA temp temporary restoration 3D printing photoreactive resin (K191590)Enlighten Materials Co., Ltd.2020-05-05
Magicore II System (K192197)Innobiosurg Co., Ltd.2020-04-28
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants (K193592)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-04-28
Implantswiss Dental Implant System and Implantswiss Dental Abutment System (K200867)Novodent SA2020-04-28
GlassLok Kits, GlassLok Powder, GlassLok Liquid (K193388)Reliance Orthodontic Products, Inc.2020-04-27
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