Atlas FDA

Dental

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

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RecordFirmDate
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) (K251544)Lakong Medical Devices Co., Ltd.2026-08-07
PacTemp Automix NE (K261937)The Belport Company Inc., DBA Gingi-Pak2026-08-07
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (K253999)Nobel Biocare AB2026-08-06
Ruthinium Disc (K261456)Dental Manufacturing S.p.A.2026-08-05
SnØreNegatØr (K261912)DnB Innovations, LLC2026-07-31
Angled Screwdriver MED (M-SD090) (K253655)W&H Dentalwerk Bürmoos GmbH2026-07-31
NanoCeram Resin (K262681)3BFAB TEKNOLOJI A.S.2026-07-31
Obsidian® Press Over Zirconia (K262239)Prismatik Dentalcraft, Inc.2026-07-30
METICULY Patient-specific CMF solution (K253206)Meticuly Co., Ltd.2026-07-25
One-Fil LC (K261728)Mediclus Co., Ltd.2026-07-21
Dental Zirconia Blank & Coloring Liquid (K261046)Hunan Qinghao Puzhong Technology Co., Ltd.2026-07-17
DIA-CEM (K261166)DiaDent Group International2026-07-09
Denture Base Resin V2 (K262300)Formlabs Ohio, Inc.2026-07-08
Cytrans™ Elashield (K253317)GC America, Inc.2026-07-06
iTero Lumina™ Pro (K261847)Align Technology , Ltd.2026-07-02
FACE4D Aligner (K260527)Avinent Implant System S.L.U.2026-07-02
OrthoFit (K261129)Spident Co., Ltd.2026-07-02
Tetric plus Fill;Tetric plus Flow (K261485)Ivoclar Vivadent, Inc.2026-07-01
DENTCA Tru Flexible (K261474)Dentca, Inc.2026-07-01
Transcend Bulk Fill Flowable Composite (K262228)Ultradent Products, Inc.2026-07-01
Neodent Implant System - NeoConvert Fit (K261147)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-07-01
Dandy Ceramic Stain and Glaze (K262195)Zima International Inc., dba Dandy2026-06-30
Zolid Lunaris (K260918)Amann Girrbach AG2026-06-29
Injectable Root Canal Sealer (KP-Root SP) (K261415)Guilin Kevin Peter Technology Co., Ltd.2026-06-29
MIST IC (K261122)Imagine Milling Technologies, LLC2026-06-27
BioHorizons CEREC Compatible Ti-Bases (K260061)BioHorizons Implant Systems, Inc.2026-06-26
UNIQA® Dental Implants System (K251188)Uniqa Dental, Ltd.2026-06-25
Curing Light (M-Cure 6) (K253131)Guangzhou Rebornendo Medical Instrument Co., Ltd.2026-06-18
MegaGen Zygoma Dental Implant System (K251232)Megagen Implant Co., Ltd.2026-06-18
Implantmed Plus II & Piezomed Plus II Module (K253776)W&H Dentalwerk Buermoos GmbH2026-06-18
SRGC-06 (K261246)GC America, Inc.2026-06-18
Dental Implant System (K250806)A.B. Dental Devices , Ltd.2026-06-18
INOSS System (K260006)Inosys, Inc.2026-06-17
BOSS (K253723)Medpark Co., Ltd.2026-06-16
Neodent Scannable Healing Abutment (K253922)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-06-15
Virtus (K261366)Somnomed, Inc.2026-06-12
Fluoride Varnish (Type A,Type C) (K253052)Nagy Oral Technology Qinhuangdao Co., Ltd.2026-06-11
Snorbliss® Anti-Snoring Device (K261251)Endeavor Commerce, LLC2026-06-11
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145)Smart Denture Conversions, LLC2026-06-11
Rosetta SM, Rosetta SP (K260859)Hass Corp.2026-06-11
DESS Dental Smart Solutions (K260564)Terrats Medical SL2026-06-09
BracePaste Prime Plus (K261840)American Orthodontics2026-06-03
VSP System (Titanium Palatal Splint) (K261826)3D Systems, Inc.2026-06-03
SIC Abutments including CAD/CAM Solutions (K252904)Sic Invent AG2026-06-03
DIAFIL (K261093)DiaDent Group International2026-06-02
DB 4000 High Impact Denture Base (K260569)Carbon, Inc.2026-06-02
Portable Dental X-ray System Model PDX nova (K260367)PDX Co., Ltd.2026-05-27
DCMhotbond zircon (K253191)Dental Creativ Management GmbH2026-05-21
Elos Accurate® Denture Fixation System (K253774)Elos Medtech Pinol A/S2026-05-20
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (K261071)DiaDent Group International2026-05-19
OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268)Bernhard Förster GmbH (Bernhard Foerster Ltd.)2026-05-19
G-CEM UNIVERSAL (K254109)GC America, Inc.2026-05-18
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372)Hiossen, Inc.2026-05-14
Dormiva Anti-Snoring Mouth Guard (K261134)Koncept Innovators, Inc.2026-05-14
Bonalive Maxillofacial (K253883)Bonalive , Ltd.2026-05-14
Any-Etch (K260485)Mediclus Co., Ltd.2026-05-14
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant (K252731)Promimic AB2026-05-12
Dual Core (K260805)Vericom Co., Ltd.2026-05-11
LingOral Dental Design System (K260419)Hangzhou ChohoTech Co., Ltd.2026-05-08
Smylio Aligners (K260788)Smylio, Inc.2026-05-08
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (K260460)Institut Straumann AG2026-05-07
Denture Base (K260376)Shandong Huge Dental Material Corporation2026-05-06
VOCO Profluorid Varnish + BioMin (K252073)Voco GmbH2026-05-01
Any-Com Seal (K260819)Mediclus Co., Ltd.2026-05-01
UltraEZ (K261404)Ultradent Products, Inc.2026-04-30
Surgical Microscope (OMS2360, OMS2380) (K252464)Zumax Medical Co., Ltd.2026-04-28
Grandio disc multicolor (K261357)Voco GmbH2026-04-27
Dura-Crown (K261356)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-04-27
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (K260152)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.2026-04-23
Dura-Arch (K261261)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-04-17
DESS Dental Smart Solutions (K253804)Terrats Medical SL2026-04-16
REGEN Bioactive Cement (K253337)Inter-Med, Inc.2026-04-15
Midas Restore (K260661)Sprintray, Inc.2026-04-15
SureSmile Aligner (ASSY500020) (K260722)Dentsply Sirona, Inc.2026-04-15
TRIOS Dx (R1) (K260082)3Shape TRIOS A/S2026-04-10
ShaeferH (K252942)Shaeferh, LLC2026-04-10
Porcelain Etch Gel (K260430)Belport Company, Inc., Gingi-Pak2026-04-10
Eternal Art Porcelain Powders (K260067)Shandong Huge Dental Material Corporation2026-04-09
LOCATOR® Angled Abutment (K260555)Zest Anchors, LLC2026-04-09
ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765)Prosomnus Sleep Technologies2026-04-06
GLOSSY COAT (15ML) (K254091)YAMAHACHI DENTAL MFG., Co.2026-04-06
Light-curing Coloring Materials (ALCM) (K253036)Aidite (Qinhuangdao) Technology Co., Ltd.2026-04-06
Leforte MMF System (K252246)Jeil Medical Corporation2026-04-02
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K260370)Bloomden Bioceramics (HuNan) Co., Ltd.2026-03-30
Adin Long Dental Implant System (K252031)Adin Dental Implant Systems , Ltd.2026-03-23
NOMAD Pro 3 (K253864)Dental Imaging Technologies Corporation2026-03-20
Bifix Veneer LC, Bifix Veneer Try-In (K252606)Voco GmbH2026-03-20
Dia-X Sil Bite (K254112)DiaDent Group International2026-03-19
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (K260830)Sangi Co., Ltd.2026-03-18
enCore Impression Material (K251926)Encore Guards2026-03-17
ZENEX Implant System_Short (R-System) (K253334)Izenimplant Co., Ltd.2026-03-16
Dental X-RAY Unit (AJX200) (K252110)Guangzhou Ajax Medical Equipment Co., Ltd.2026-03-12
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783)Kulzer, LLC2026-03-11
Varios Combi Pro2 (K260773)Nakanishi, Inc.2026-03-10
IPS e.max Zirconia (K253953)Ivoclar Vivadent, Inc.2026-03-10
Straumann® BLC Implants - Indication Widening (K252168)Institut Straumann AG2026-03-10
BONTREE PLUS (K251818)Hudens Bio Co., Ltd.2026-03-06
Adhese 2 (K252450)Ivoclar Vivadent, Inc.2026-03-05
Dentis SQ-SL AXEL Fixture (K253493)Dentis Co., Ltd.2026-03-04
SureSmile Software (K253565)Dentsply Sirona, Inc.2026-03-04
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