Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2026-04-28
Clearances · page 2 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | NBL | Class II | 2026-04-28 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBF | Class II | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | EBF | Class II | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | EBF | Class II | 2026-04-23 |
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBG | Class II | 2026-04-17 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2026-04-16 |
| K260661 | Midas Restore | Sprintray, Inc. | EBF | Class II | 2026-04-15 |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | EMA | Class II | 2026-04-15 |
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | NXC | Class II | 2026-04-15 |
| K260082 | TRIOS Dx (R1) | 3Shape TRIOS A/S | SHQ | Class II | 2026-04-10 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | KLE | Class II | 2026-04-10 |
| K252942 | ShaeferH | Shaeferh, LLC | LRK | Class II | 2026-04-10 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | NHA | Class II | 2026-04-09 |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | EIH | Class II | 2026-04-09 |
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | EBD | Class II | 2026-04-06 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | EBF | Class II | 2026-04-06 |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | PLC | Class II | 2026-04-06 |
| K252246 | Leforte MMF System | Jeil Medical Corporation | JEY | Class II | 2026-04-02 |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | EIH | Class II | 2026-03-30 |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | DZE | Class II | 2026-03-23 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | EMA | Class II | 2026-03-20 |
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | EHD | Class II | 2026-03-20 |
| K254112 | Dia-X Sil Bite | DiaDent Group International | ELW | Class II | 2026-03-19 |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | LBH | Class II | 2026-03-18 |
| K251926 | enCore Impression Material | Encore Guards | SHI | Class II | 2026-03-17 |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | DZE | Class II | 2026-03-16 |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | EHD | Class II | 2026-03-12 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | EBF | Class II | 2026-03-11 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | DZE | Class II | 2026-03-10 |
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | ELC | Class II | 2026-03-10 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | EIH | Class II | 2026-03-10 |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | LYC | Class II | 2026-03-06 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | KLE | Class II | 2026-03-05 |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | DZE | Class II | 2026-03-04 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | NHA | Class II | 2026-03-04 |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | PNN | Class II | 2026-03-04 |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | LRK | Class II | 2026-03-03 |
| K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | KLE | Class II | 2026-03-03 |
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | MUH | Class II | 2026-03-03 |
| K254245 | ZAFIRA® | New Stetic, SA | EBF | Class II | 2026-03-03 |
| K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. | EBG | Class II | 2026-03-02 |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | LRK | Class II | 2026-03-02 |
| K251724 | Remi Impression Material | Grindguard, Inc. | SHI | Class II | 2026-02-25 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | KLE | Class II | 2026-02-23 |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | EHD | Class II | 2026-02-19 |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | DZE | Class II | 2026-02-18 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | NHA | Class II | 2026-02-10 |
| K253282 | ZSmile System | Dror Orthodesign , Ltd. | NXC | Class II | 2026-02-03 |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | EHD | Class II | 2026-02-03 |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | DZE | Class II | 2026-02-02 |
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | EBW | Class I | 2026-01-30 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | EIH | Class II | 2026-01-30 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | NHA | Class II | 2026-01-29 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | NHA | Class II | 2026-01-29 |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | ELC | Class II | 2026-01-28 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2026-01-22 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | NHA | Class II | 2026-01-22 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBF | Class II | 2026-01-21 |
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | EJK | Class II | 2026-01-13 |
| K251388 | 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) | Foshan Topmed Dental Co., Ltd. | EFB | Class I | 2026-01-12 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | EBW | Class I | 2026-01-12 |
| K253167 | Any-Paste | Mediclus Co., Ltd. | KIF | Class II | 2026-01-12 |
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | EFB | Class I | 2026-01-12 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | EIH | Class II | 2026-01-09 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | DZE | Class II | 2026-01-08 |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | NXC | Class II | 2026-01-07 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2026-01-07 |
| K252507 | SmileInspector | Amv Consulting, LLC | PNN | Class II | 2026-01-07 |
| K252890 | ZenSeal Pro | Kerr Corporation | KIF | Class II | 2026-01-07 |
| K253343 | Celebrace Software | Celebrace | PNN | Class II | 2025-12-29 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | DZE | Class II | 2025-12-23 |
| K253341 | Custom Abutments AS | Medentika GmbH | NHA | Class II | 2025-12-23 |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | DZI | Class II | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | NHA | Class II | 2025-12-23 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | 2025-12-23 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | DZE | Class II | 2025-12-22 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | EMA | Class II | 2025-12-19 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | JEY | Class II | 2025-12-19 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | NHA | Class II | 2025-12-18 |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | LRK | Class II | 2025-12-18 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | EMA | Class II | 2025-12-12 |
| K242817 | Jason membrane | Botiss Biomaterials GmbH | NPL | Class II | 2025-12-12 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | DZE | Class II | 2025-12-12 |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | EMA | Class II | 2025-12-09 |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | NHA | Class II | 2025-12-09 |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | 2025-12-08 |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | NPL | Class II | 2025-12-05 |
| K252465 | Any-Core | Mediclus Co., Ltd. | EBF | Class II | 2025-12-05 |
| K252151 | els unibond | Saremco Dental AG | KLE | Class II | 2025-12-05 |
| K253868 | QuietLab Pro | QuietLab, LLC | LRK | Class II | 2025-12-05 |
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | DYW | Class II | 2025-11-27 |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | NHA | Class II | 2025-11-26 |
| DEN240077 | MuReva OM | Mureva Phototherapy, Inc. | SGQ | Class II | 2025-11-26 |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | LRK | Class II | 2025-11-25 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | EBI | Class II | 2025-11-25 |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | NPL | Class II | 2025-11-25 |
| K250714 | FluoroDose Varnish | Centrix, Inc. | LBH | Class II | 2025-11-21 |
| K253681 | 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) | Graphy, Inc. | EBI | Class II | 2025-11-21 |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | NHA | Class II | 2025-11-21 |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | EBI | Class II | 2025-11-20 |
12,679 clearances in the Dental panel. Data: openFDA.