Atlas FDA

Dental

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

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RecordFirmDate
MRI Compatibility for Existing Neodent Implant System (K182620)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-01-18
SLEEPAPP (K182202)Comfort Acrylics, Inc.2019-01-11
MTA2.3 MATERIALS (K181917)NuSmile, Ltd.2019-01-11
Fit SA (K182869)Shofu Dental Corporation2019-01-09
Park Dental Research Aligners (K180648)Park Dental Research Corporation2019-01-08
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (K180564)Medentika GmbH2019-01-07
Stryker Facial iD Plating System (K182305)Stryker2019-01-07
BIO-C TEMP (K180199)Angelus Industria DE Produtos Odontologicos S/A2019-01-04
Straumann PURE Ceramic Implant System (K180477)Institut Straumann AG2019-01-04
Clear Image Aligners (K183643)Specialty Appliance Works, Inc.2019-01-03
3M Filtek Universal Restorative (K183476)3M Espe Dental Products2019-01-02
Signature Orthodontic System (K183542)Signature Orthodontics2019-01-02
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (K181703)Institut Straumann AG2018-12-28
CranioMaxillofacial Fixation (CMF) System - CMF Visionare (K180204)Visionare, LLC2018-12-28
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White (K181331)Juvora, Ltd.2018-12-21
DIO CAD/CAM Abutment (K181037)Dio Corporation2018-12-21
Neocis Guidance System (K182776)Neocis, Inc.2018-12-21
VINTAGE PRO (K181496)Shofu Dental Corporation2018-12-18
Lucitone Denture Base Materials (K182422)Dentsply Sirona2018-12-18
UV Active Implant System (K182194)Dio Corporation2018-12-14
HyperFil-LV (K182296)Parkell, Inc.2018-12-14
PYRAMIDION Dental Implants and Prostheses (K180859)Dentack Implants, Ltd.2018-12-13
EVOLUX CAD/CAM PMMA BLOCKS (K182065)Blue Dent Dental2018-12-13
Erran Dental Zirconia (K182068)Hangzhou Erran Technology Co., Ltd.2018-12-13
Harvest Dental Polymer Blocks (K180578)Harvest Dental Products, LLC2018-12-12
On1 Universal Abutment (K181869)Nobel Biocare AB2018-12-12
Resin for Temporary Crown & Bridge (K180657)Dentis Co., Ltd.2018-12-07
Elevo® Kit Snoring Intervention Device (K181107)Zelegent, Inc.2018-12-06
NobelZygoma 0° (K183069)Nobel Biocare AB2018-12-04
Ceramic Denture Zirconia Ceramics Block (K181816)Qinhuangdao Silide Ceramic Technology Co., Ltd.2018-11-29
Implant-One System (K173701)Implant Logistics, Inc.2018-11-29
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite (K181604)Hrs Co., Ltd.2018-11-28
3M Clarity Aligners (K183159)3M Company2018-11-26
Orchestrate 3D (K181112)Orchestrate 3D2018-11-26
A.B. Dental Devices Dental Implants System (K181381)A.B. Dental Device , Ltd.2018-11-23
DENTIOIII series (DENTIOIII, DENTIOIII-S) (K181297)Hdx Will Corp.2018-11-21
ApnoDent Appliance (K181123)Apnomed, Inc.2018-11-21
TPH Spectra ST Flowable Composite Restorative (K182288)Dentsply Sirona2018-11-20
GC Acrylic Primer (K180917)GC America, Inc.2018-11-20
Oral Device OA, Oral Device S (K181396)Passion For Life Healthcare (Uk) Limited2018-11-16
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System (K180184)Dentalpoint AG2018-11-16
IT-III active System (K181137)Neobiotech Co., Ltd.2018-11-16
Nexcomp (K181689)Meta Biomed Co., Ltd.2018-11-15
K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent (K173971)Yeti Dentalprodukte GmbH2018-11-15
Inversa Implants (K181850)Southern Implants (Pty), Ltd.2018-11-14
Apoller Flow Light Cure Flowable Composite (K180463)Greenway Yw, LLC2018-11-14
Blue Sky Bio Computerized Orthodontic Bracket System (K182338)Blue Sky Bio2018-11-09
SureCure Orthodontic Aligner System (K182329)Digital Orthodontic Care2018-11-08
OptiBond eXTRa Universal (K182162)Kerr Corporation2018-11-07
W Zirconia Implants (K172668)Tav Medical , Ltd.2018-11-06
SaliPen (K180838)Saliwell , Ltd.2018-11-06
Implantswiss Dental Implant System, Implantswiss Dental Abutment System (K181266)Novodent SA2018-11-01
LUXEN Zr, LUXEN Smile (K171585)Dentalmax Co., Ltd.2018-10-31
Universal Base Abutment (K180899)Nobel Biocare AB2018-10-31
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (K180718)Tomy, Inc.2018-10-30
Biomate Dental Implant System (K170732)Biomate Medical Devices Technology Co., Ltd.2018-10-26
Invisalign System with Mandibular Advancement Feature (K181739)Align Technology, Inc.2018-10-26
Sonendo Material A (K181922)Sonendo, Inc.2018-10-22
Straumann cerabone (K173594)Institut Straumann AG2018-10-19
Ortho System (K180941)3Shape A/S2018-10-17
BracePaste MTP Light Cure Primer (K181910)American Orthodontics2018-10-15
Juell 3D Volo Base (K181220)Park Dental Research Corporation2018-10-12
OmniPore DUROMAX Surgical Implants (K180249)Matrix Surgical Holdings, LLC/Matrix Surgical USA2018-10-11
Ormco Spark Aligner System (K182826)Sybron Dental Specialties2018-10-11
LS OIL (K173920)J. Morita USA, Inc.2018-10-11
Sirona Dental CAD/CAM System (K181520)Dentsply Sirona2018-10-11
BioHorizons Tapered IM Implants (K182070)BioHorizons Implant Systems, Inc.2018-10-10
Straumann SC Variobase Abutments (K173945)Institut Straumann AG2018-10-05
IS-III active System (K181138)Neobiotech Co., Ltd.2018-10-03
BioHorizons CAD/CAM Bars (K180998)BioHorizons Implant Systems, Inc.2018-09-28
Orthocaps Twinaligner (K180241)Ortho Caps GmbH2018-09-28
Prime&Bond active Universal Adhesive (K181476)Dentsply Sirona2018-09-28
BeautiBond Universal (K180803)Shofu Dental Corporation2018-09-26
CSM Submerged3-L Implant System (K173141)Csm Implant2018-09-19
RiX70 DC (K182206)Trident S.R.L2018-09-13
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)KLS-Martin L.P.2018-09-13
HySil Impression Materials (K181236)Osstem Implant Co., Ltd.2018-09-13
Stryker Pediatric Mandibular Distractor 2 (K181504)Stryker2018-09-11
TruBase S (K171532)Truabutment, Inc.2018-09-11
Provata Implant System (K180465)Southern Implants (Pty), Ltd.2018-09-06
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid (K181167)Liaoning Upcera Co., Ltd.2018-09-02
myTAP2 (K181482)Airway Management, Inc.2018-08-31
BIO-C REPAIR (K180185)Angelus Industria DE Produtos Odontologicos S/A2018-08-31
Anchor plate (K173623)Biomaterials Korea, Inc.2018-08-30
Neodent Implant System – GM Line (K180536)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2018-08-30
Meta P&Bond (K180802)Meta Biomed Co., Ltd.2018-08-29
Smylic Invisible Clear Aligners (K173784)Smylio, Inc.2018-08-23
MATRx plus (DEN170090)Zephyr Sleep Technologies2018-08-23
Z-CAD smile (K170050)Metoxit AG2018-08-23
GrandioSO x-tra (K181312)Voco GmbH2018-08-22
Young INFINITY Cordless Handpiece System (K171377)Young Dental Manufacturing Co. 1, LLC2018-08-20
BTI Dental Implant System UnicCa (K173257)B.T.I. Biotechnology Institute, Sl.2018-08-17
OsteoReady Dental Implant System (K173575)Osteoready, LLC2018-08-17
Forest Dental Unit (K173608)Forest Dental Products, Inc.2018-08-17
Bongo (K180619)Innomed Healthscience, Inc.2018-08-16
BRILLIANT Crios (K181500)Coltene/Whaledent AG2018-08-15
InterActive SMARTBase Abutments (K181359)Implant Direct Sybron Manufacturing, LLC2018-08-15
KLS Martin Individual Patient Solutions (K180962)KLS-Martin L.P.2018-08-13
Portable X-ray System (Model: MiniX-V, Mini X-S) (K181891)Digimed Co., Ltd.2018-08-10
MyPlant II Implant System (K173819)Hager& Meisinger GmbH2018-08-09
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