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Dental

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

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RecordFirmDate
SunClear Aligner system (K190394)Sun Dental Laboratories, LLC2019-12-16
Llis, Vittra APS (K191306)Dentscare Ltda2019-12-16
Ambar, Ambar APS, Ambar Universal APS (K183424)Dentscare Ltda2019-12-13
BIO-C Sealer Ion+ (K190537)Angelus Industria DE Produtos Odontologicos S/A2019-12-12
SleepTight Mouthpiece STZ (K191618)Michael D Williams Dds PA2019-12-11
EVO 450 series High Speed Handpieces (K190508)Ttbio Corp.2019-12-11
MIS Dental Implant System (K192149)Dentsply Sirona, Inc.2019-12-11
Dental high speed handpiece, Dental low speed handpiece (K181900)Foshan Cicada Dental Instrument Co, Ltd.2019-12-09
Straumann Mini Implants (K191895)Institut Straumann AG2019-12-09
Southern Implants MAX Implant System (K191054)Southern Implants (Pty), Ltd.2019-12-09
TSV BellaTek Express and BellaTek Flex Abutments (K192522)Biomet 3i, LLC2019-12-09
JJ Implant System (K190552)Jj Implants2019-12-06
MCI - CMF System (K182758)Mci Medical Concept Innovation, Inc.2019-12-05
Digital Intraoral Imaging Plate System (K192766)Fsusen Technology Co., Ltd.2019-12-05
Neodent Implant System - Temporary Abutments (K191191)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-12-05
Southern Implants PEEK Abutments (K191250)Southern Implants (Pty), Ltd.2019-12-05
Zipbond (K191656)Sdi Limited2019-12-02
3Shape Splint Design (K191911)3Shape A/S2019-11-27
TRAUS Dental Handpieces (K182892)Saeshin Precision Co., Ltd.2019-11-26
DEXIS CariVu 3-in-1 by KaVo (K182712)Kaltenbach & Voigt GmbH2019-11-23
Parkell Desensitizer Gel (K191103)Parkell, Inc.2019-11-22
KLS Martin Individual Patient Solutions (K191028)KLS-Martin L.P.2019-11-22
Color Liquid, Vita Liquid (K190518)Zirkonzahn Srl2019-11-22
BruxZir GT (Gum Tissue) Color (K191903)Prismatik Dentalcraft, Inc.2019-11-22
everX Flow (K192260)GC America, Inc.2019-11-22
SmartLite Pro Modular LED Curing Light (K191865)Dentsply Sirona2019-11-20
SDS1.2 dental implant (K181953)Sds Swiss Dental Solutions AG2019-11-20
FluoroCal (K182917)Bisco, Inc.2019-11-18
CLEARFIL MAJESTY ES Flow (K191980)Kuraray Noritake Dental, Inc.2019-11-18
ROSA Bracket (K182672)Gni Co., Ltd.2019-11-15
EM SA Implant System (K191201)Hiossen, Inc.2019-11-15
ST Internal Implant System (K192347)Megagen Implant Co., Ltd.2019-11-14
Clear21 (K192202)World Class Technology Corporation2019-11-12
DESS Dental Smart Solutions (K191986)Terrats Medical SL2019-11-10
Neodent Implant System (K190958)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-11-09
Visalys CemCore, Visalys Cem Core Try In Paste (K191527)Kettenbach GmbH & Co. KG2019-11-08
BA Pit & Fissure Sealant (K190998)Apex Dental Materials, Inc.2019-11-08
StoneBite and StoneBite scan (K190571)Dreve Dentamid GmbH2019-11-07
Portux CAD/CAM Disc (K192153)New Stetic, SA2019-11-07
Vivid Aligners (K190003)Orthodent Laboratory, Inc.2019-11-06
BIO-RAY A-1 Anchor Screw System (K182929)Microware Precision Co., Ltd.2019-11-06
Suglue 3 (K192992)3M Deutschland GmbH2019-11-05
Mei Ceramic Bracket (K190608)Orthosun Co., Ltd.2019-11-04
EthanZir Zirconia (K191304)Besorah Dental Solutions NZ Limited2019-11-04
Scan Abutments and Comfort Caps (K191634)Dentium Co., Ltd.2019-11-04
Allcem, Allcem Core (K183465)Dentscare Ltda2019-11-02
ZMAXX Dental Zirconia Blanks (K191631)Zmaxx Bioceramics, LLC2019-11-01
NextDent Denture 3D+ (K191497)Vertex-Dental B.V.2019-11-01
VPro5 (K183018)Propel Orthodontics, LLC2019-11-01
ADH19 (K192961)3M Deutschland GmbH2019-10-31
BRILLIANT COMPONEER (K191385)Coltene/Whaledent AG2019-10-29
W Zirconia Implants (K192053)Tav Medical , Ltd.2019-10-29
Straumann PUREloc abutments (K192029)Institut Straumann AG2019-10-28
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (K190124)E.M.S Electro Medical Systems S.A2019-10-20
Nexus Universal Self-Cure (K191548)Kerr Corporation2019-10-11
Razor, Everest, U&C Liquid (K191902)U&C International Co., Ltd.2019-10-11
Legacy SMARTBase Abutments (K191458)Implant Direct Sybron Manufacturing, LLC2019-10-10
Visalys Restorative Primer (K191523)Kettenbach GmbH & Co. KG2019-10-09
AnyRidge Octa 1 Implant System (K182448)Megagen Implant Co., Ltd.2019-10-09
KATANA Cleaner, KATANA Cleaner (Trial) (K191133)Kuraray Noritake Dental, Inc.2019-10-08
Advanced Intermezzo Implant System (K191127)Megagen Implant Co., Ltd.2019-10-08
Ceramill A-Temp (K191843)Amann Girrbach AG2019-10-04
Tokuyama Rebase III (K190940)Tokuyama Dental Corporation2019-10-04
Vintage Art Universal (K191794)Shofu Dental Corporation2019-10-03
ALFA GATE Dental Implants System (K182143)Alfa Gate Mazen, Ltd.2019-10-03
Neocis Planning Software Application (NPSA) for 3rd Party PCs (K191363)Neocis, Inc.2019-10-02
SmileAlign Orthodontic Aligner System (K191774)3D Global Biotech, Inc.2019-09-30
UF(II) Anatomic abutment (K190048)Dio Corporation2019-09-30
Visalys Tooth Primer (K191524)Kettenbach GmbH & Co. KG2019-09-29
CEREC Guides (K190059)Dentsply Sirona2019-09-27
Dia-Proseal (K182009)DiaDent Group International2019-09-26
Novidia Universal Bond (K183391)Nobio , Ltd.2019-09-24
Sapphire Dorsal Comfort Fit (K181416)Crane Dental Laboratory, Inc.2019-09-17
Infinix Universal Composite (K182921)Nobio , Ltd.2019-09-13
OrthoAnalysis Software (K183695)Inteware Co., Ltd.2019-09-12
Neocis Guidance System (NGS) (K191605)Neocis, Inc.2019-09-11
TurboTemp EZ (K191619)Zest Anchors, LLC2019-09-11
Klinly Ultrasonic Tongue Cleaner (K181986)Kea Products, Ltd.2019-09-06
SmarTemp X1 (K190930)Parkell, Inc.2019-09-05
3M Clarity Aligners (K192119)3M Company2019-09-05
Opus Bulk Fill APS, Opus Bulk Fill Flow APS (K190758)Dentscare Ltda2019-09-04
VPS Impression Material (K191034)Hygedent, Inc.2019-09-04
K3 (K183347)Osstem Implant Co., Ltd.2019-09-04
O2Vent Optima (K190236)Oventus Manufacturing Pty, Ltd.2019-08-29
SGS Dental Implants System (K182219)Sgs International, Ltd.2019-08-29
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal (K192042)Geistlich Pharma AG2019-08-29
IPS e.max CAD Abutment Solutions- extra systems (K191382)Ivoclar Vivadent, AG2019-08-26
Halley resin system (K191427)Dentsply Sirona2019-08-26
OSW Aligner System (K191990)Osw Manufacturing, LLC2019-08-23
Osstell Beacon (K181888)Osstell AB2019-08-22
ScanX Touch/ScanX Duo Touch (K191623)Air Techniques, Inc.2019-08-21
Piezon Built-in Kit, Piezon Built-in Kit LED (K191079)E.M.S Electro Medical Systems S.A2019-08-16
IS-III active System_S-narrow Type (K190849)Neobiotech Co., Ltd.2019-08-14
Blue Sky Bio Zygomatic Implant System (K190491)Blue Sky Bio, LLC2019-08-12
Bone Screw, Bone Tack (K182881)Osstem Implant Co., Ltd.2019-08-09
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV (K191222)Prismatik Dentalcraft, Inc.2019-08-05
Shaders ZR (K190569)Digital Age Dental Lab2019-07-29
Helioseal F Plus (K190339)Ivoclar Vivadent, AG2019-07-29
Maxima Electric System (K180845)Handpiece Headquarters - Hpr, Inc.2019-07-25
Qraypen (K183121)AIOBIO Co., Ltd.2019-07-18
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