Atlas FDA

Dental

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

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RecordFirmDate
Healing Abutment System (K251434)Osstem Implant Co., Ltd.2026-03-04
ZAFIRA® (K254245)New Stetic, SA2026-03-03
Bond-PR™ Universal Adhesive (K260682)Premier Dental Products Company2026-03-03
SOTA Cloud Smart Sensor (1.5) (K251793)Sota Cloud Corp.2026-03-03
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (K253845)Ram.Shaw Pte. , Ltd.2026-03-03
“FLNT Base” and “FLNT Temp” (K253380)Liaoning Upcera Co., Ltd.2026-03-02
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (K252531)Myofunctional Research Co.2026-03-02
Remi Impression Material (K251724)Grindguard, Inc.2026-02-25
VITA VMLC Primer (K251587)Vita Zahnfabrik H. Rauter GmbH & Co. Kg.2026-02-23
Portable Dental X-ray Device (GT-1) (K254018)Guilin Refine Medical Instrument Co., Ltd.2026-02-19
Nobel Biocare S Series Implants (K252197)Nobel Biocare AB2026-02-18
Solidex® Ti-Links and Screws (K251515)CreoDent Hudson Valley2026-02-10
ZSmile System (K253282)Dror Orthodesign , Ltd.2026-02-03
Diagnostic X-Ray Equipment Model POCT22 (K252909)Ningbo Runyes Medical Instrument Co., Ltd.2026-02-03
BIORES Dental Implant System (K252286)Chengdu Besmile Medical Technology Co., Ltd.2026-02-02
BruxZir® Shaded 16 PLUS (K254283)Prismatik Dentalcraft, Inc.2026-01-30
Motor Handpiece and Control Unit (SDI10) (K251407)Saeshin Precision Co., Ltd.2026-01-30
EK MULTI ANGLED 30 ABUTMENT (K251427)Hiossen, Inc.2026-01-29
Multi-Unit DAS System (K243732)Talladium España, SL2026-01-29
GBT Machine Airflow Prophylaxis Master (K253254)E.M.S Electro Medical Systems S.A2026-01-28
IPDmilled Blanks (K253253)Implant Protesis Dental 2004, S.L.2026-01-22
Straumann Variobase Abutments XC for Bridge/Bar (K253315)Institut Straumann AG2026-01-22
LumiCera (K260170)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-01-21
Bright Cavity Liner (K253248)Dmp Dental Industry S.A.2026-01-13
Any-Paste (K253167)Mediclus Co., Ltd.2026-01-12
High speed air turbine handpiece (K251389)Foshan Topmed Dental Co., Ltd.2026-01-12
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (K251388)Foshan Topmed Dental Co., Ltd.2026-01-12
Star E900 Electric System (K251701)Dentalez, Inc., Stardental Division2026-01-12
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (K253973)Liaoning Upcera Co., Ltd.2026-01-09
ZENEX Implant System_R-System (K252585)Izenimplant Co., Ltd.2026-01-08
Clear Aligner (SCF-3348) (K251454)Beame Medical Technology (Shenzhen) Limited2026-01-07
SmileInspector (K252507)Amv Consulting, LLC2026-01-07
ZenSeal Pro (K252890)Kerr Corporation2026-01-07
Neodent InLab Validated Workflow (K252727)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-01-07
Celebrace Software (K253343)Celebrace2025-12-29
GEN5™ and GEN5+™ 3.3mmD Dental Implants (K252145)Paragon Implant Mfg., LLC2025-12-23
Custom Abutments AS (K253341)Medentika GmbH2025-12-23
OrangeCAD Med Abutments (K253312)Orangecad Med GmbH2025-12-23
NizPlant Dental Implant System (K250476)Paragon Implant Mfg., LLC2025-12-23
VarioSurg 4 (K254163)Nakanishi, Inc.2025-12-23
DIMPLO Implant System (K251605)DIMPLO, Ltd.2025-12-22
iCEM Universal Plus (K254063)Kulzer, LLC2025-12-19
Southern Craniomaxillofacial (CMF) System (K253373)Southern Medical (Pty) , Ltd.2025-12-19
SIMDA Abutments (K252320)Simda Co., Ltd.2025-12-18
Park Dental Nylon MAD (K252976)Park Dental Research Corp.2025-12-18
TopCEM Vigor SA Self-Adhesive Resin Cement (K252785)Rizhao Huge Biomaterials Company, Ltd.2025-12-12
Pterygoid Indication for GM Helix Implants (K252090)JJGC Indústria e Comércio de Materiais Dentários S.A.2025-12-12
Jason membrane (K242817)Botiss Biomaterials GmbH2025-12-12
GlasIonomer FX-LC (K252808)Shofu Dental Corporation2025-12-09
Atlantis® Abutments in Titanium (K252343)Dentsply Sirona2025-12-09
Glass Ceramic (K252789)Shenzhen Xiangtong Co., Ltd.2025-12-08
Augmented Gingival Matrix (K250512)Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.2025-12-05
QuietLab Pro (K253868)QuietLab, LLC2025-12-05
els unibond (K252151)Saremco Dental AG2025-12-05
Any-Core (K252465)Mediclus Co., Ltd.2025-12-05
Carriere® Motion Pro® Clear Bite Corrector (K252760)Ortho Organizers, Inc.2025-11-27
CEREC Tessera Abutment System (K252248)Dentsply Sirona2025-11-26
MuReva OM™ (DEN240077)Mureva Phototherapy, Inc.2025-11-26
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (K252253)Geistlich Pharma AG2025-11-25
Hushd Avera (K252161)Good Sleep CO Pte , Ltd.2025-11-25
LuxCreo Flexible Partial Denture Resin (K253365)LuxCreo, Inc.2025-11-25
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (K251205)Dentsply Sirona2025-11-21
FluoroDose Varnish (K250714)Centrix, Inc.2025-11-21
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) (K253681)Graphy, Inc.2025-11-21
UltraPrint-Dental Denture UV (K253324)Guangzhou Heygears IMC., Inc.2025-11-20
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (K252582)Prismatik Dentalcraft, Inc.2025-11-18
EzSensor HD, EzSensor UHD (K252570)Qpix Solutions, Inc.2025-11-10
Primeprint Direct Aligner (K250739)Dreve Dentamid GmbH2025-11-07
MultiMatch Flow Chameleon AntiMicrobial Composite (K253513)Premier Dental Products Company2025-11-07
S.I.N. Tapered Pro Conical Zygoma Implant System (K251129)S.I.N. Implant System Ltda2025-11-07
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (K251441)Inion OY2025-11-07
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (K252469)Dmp Dental Industry S.A.2025-11-06
AIO Breathe (K252525)Aiomega, LLC2025-11-06
NightGuard Aire Max (K252698)Nightguard Express, LLC2025-11-03
Midmark Dental Delivery System (K251626)Midmark Corporation2025-11-03
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (K253501)Vigodent Indústria E Comercio Ltda2025-10-31
DESS Dental Smart Solutions (K251547)Terrats Medical SL2025-10-31
GEN5 and GEN5+ Dental Implant System (K251938)Paragon Implant Mfg., LLC2025-10-30
Freeprint® denture flex (K252430)Detax GmbH2025-10-30
Difiney Advanced Anti Snoring Device 4.0 (K253355)Fissiontech, LLC2025-10-29
Yomi S Robotic System (K252376)Neocis, Inc.2025-10-28
ZIRCONOMER P (K252165)Shofu Dental Corporation2025-10-28
Cocoon Solo (DX-7020s) (K250687)Dexcowin Global, Inc.2025-10-24
Hushd Pro Z-Link (K251784)Good Sleep CO Pte , Ltd.2025-10-24
DESS® Dental Smart Solutions (K252384)Terrats Medical SL2025-10-23
Invisalign® Palatal Expander System (K252931)Align Technology, Inc.2025-10-23
Mandibular Advancement Device L07 (K251628)Dcstar, Inc.2025-10-22
S.I.N. Dental Implant System (K252266)S.I.N. Implant System Ltda2025-10-17
Adin Customized Abutments (K250178)Adin Dental Implant Systems , Ltd.2025-10-17
Alpha Endo Handpiece (Alpha Endo) (K252223)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.2025-10-16
Elos Accurate Hybrid Base (K251497)Elos Medtech Pinol A/S2025-10-16
Bonafix Implant Abutments (K251294)Zentek Medical, LLC2025-10-15
LOCATOR® Angled Abutment (K252944)Zest Anchors, LLC2025-10-15
Demi Pro (K253461)Meta Systems Co., Ltd.2025-10-14
Yomi Robotic System (K251835)Neocis, Inc.2025-10-10
HexaPLUS S OneDrill Implant System (K243078)Osseofuse International, Inc.2025-10-10
Invisalign Specifix Attachment System (K252870)Align Technology, Inc.2025-10-09
Anti Snore Mouthpiece (K250028)Dongguan Yiyao Science & Technology Development Co., Ltd.2025-10-03
G-Bond Universal (K251124)GC America, Inc.2025-10-02
G-BLOCK (K253236)Graphenano Dental S.L.2025-09-29
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