Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 32
- Latest Decision
- 2025-06-24
Clearances · page 4 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243009 | MIST IC | Imagine Milling Technologies, LLC | NHA | Class II | 2025-06-24 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | EBG | Class II | 2025-06-23 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | EMA | Class II | 2025-06-20 |
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | OAT | Class II | 2025-06-19 |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | DZE | Class II | 2025-06-18 |
| K242978 | Geo Abutment | Geomedi Co,., Ltd. | NHA | Class II | 2025-06-16 |
| K250826 | Multi M Series | Dmax Co., Ltd. | EIH | Class II | 2025-06-12 |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | KIF | Class II | 2025-06-11 |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | EBF | Class II | 2025-06-06 |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | DZE | Class II | 2025-06-06 |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | EIH | Class II | 2025-06-05 |
| K250804 | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | EBD | Class II | 2025-06-04 |
| K242897 | Partial Flex | Clemde SA DE CV | EBI | Class II | 2025-06-03 |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | EBF | Class II | 2025-05-30 |
| K243530 | Dynamic TiBase | Talladium España, SL | NHA | Class II | 2025-05-30 |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | EIH | Class II | 2025-05-29 |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | EGS | Class I | 2025-05-28 |
| K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | NHA | Class II | 2025-05-27 |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | EIA | Class I | 2025-05-27 |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | EBF | Class II | 2025-05-27 |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC | LBH | Class II | 2025-05-27 |
| K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | EBF | Class II | 2025-05-23 |
| K250639 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2025-05-22 |
| K251239 | GrandioSO Unlimited | Voco GmbH | EBF | Class II | 2025-05-21 |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | NXC | Class II | 2025-05-21 |
| K250489 | FP3D | Keystone Industries | EBI | Class II | 2025-05-20 |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2025-05-20 |
| K250122 | SleepRight Snore Aid | Splintek, Inc. | LRK | Class II | 2025-05-19 |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | DZE | Class II | 2025-05-14 |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | EIH | Class II | 2025-05-12 |
| K250763 | Reon | C.E.I.B.Med | EBF | Class II | 2025-05-12 |
| K251425 | turbodent touch | Mectron S.P.A. | KOJ | Class II | 2025-05-09 |
| K243824 | Preat Abutments | Preat Corporation | NHA | Class II | 2025-05-08 |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | LRK | Class II | 2025-05-08 |
| K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | DZE | Class II | 2025-05-08 |
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | PHR | Class II | 2025-05-07 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | EBG | Class II | 2025-05-05 |
| K242386 | Bluemoon | Genoss Co., Ltd. | EBZ | Class II | 2025-05-05 |
| K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | NHA | Class II | 2025-05-01 |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | EBF | Class II | 2025-04-30 |
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | NHA | Class II | 2025-04-30 |
| K250617 | Apex Flex | Sprintray, Inc. | EBI | Class II | 2025-04-29 |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | EKX | Class I | 2025-04-24 |
| K250198 | Laon Ortho | Laon Medi, Inc. | PNN | Class II | 2025-04-23 |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | NHA | Class II | 2025-04-22 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | EBG | Class II | 2025-04-22 |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | DYW | Class II | 2025-04-21 |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | DZE | Class II | 2025-04-21 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | NPL | Class II | 2025-04-15 |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | EBF | Class II | 2025-04-14 |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | EBW | Class I | 2025-04-11 |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2025-04-11 |
| K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | NHA | Class II | 2025-04-11 |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | EBZ | Class II | 2025-04-11 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | EBI | Class II | 2025-04-11 |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | EBZ | Class II | 2025-04-10 |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | NXC | Class II | 2025-04-08 |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | NBL | Class II | 2025-04-04 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBI | Class II | 2025-03-31 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | EKX | Class I | 2025-03-21 |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | KIF | Class II | 2025-03-14 |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2025-03-14 |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co. KG | EBF | Class II | 2025-03-14 |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | NPM | Class II | 2025-03-07 |
| K232383 | iPhysio® System | Euroteknika | NHA | Class II | 2025-03-04 |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | EFB | Class I | 2025-02-28 |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | PHR | Class II | 2025-02-28 |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | 2025-02-25 |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2025-02-24 |
| K243278 | Custom Abutments | Institut Straumann AG | NHA | Class II | 2025-02-21 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | EBG | Class II | 2025-02-21 |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | DZJ | Class II | 2025-02-21 |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | LYC | Class II | 2025-02-21 |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | EIH | Class II | 2025-02-21 |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | NXC | Class II | 2025-02-20 |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | EIA | Class I | 2025-02-19 |
| K243478 | Straumann InLab Validated Workflow | Institut Straumann AG | NHA | Class II | 2025-02-19 |
| K243212 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2025-02-14 |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | KIF | Class II | 2025-02-13 |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | ELC | Class II | 2025-02-13 |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | DZE | Class II | 2025-02-11 |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | EIA | Class I | 2025-02-07 |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | EBF | Class II | 2025-02-07 |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | DZE | Class II | 2025-01-29 |
| K231297 | Firstar Dental Unit | Firstar Dental Company | EIA | Class I | 2025-01-27 |
| K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | NHA | Class II | 2025-01-17 |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | NXC | Class II | 2025-01-16 |
| K243272 | LOCATOR Angled Abutment | Zest Anchors, LLC | NHA | Class II | 2025-01-14 |
| K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | NHA | Class II | 2025-01-13 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | EMA | Class II | 2025-01-10 |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | DZE | Class II | 2025-01-08 |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. | NHA | Class II | 2025-01-08 |
| K241489 | ReminGel | Inter-Med, Inc. | LBH | Class II | 2025-01-08 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2025-01-06 |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Ormco Corporation | DYH | Class II | 2025-01-03 |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | DZL | Class II | 2025-01-03 |
| K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | NHA | Class II | 2025-01-03 |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | LBH | Class II | 2025-01-02 |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | DZE | Class II | 2024-12-27 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | ELW | Class II | 2024-12-27 |
12,679 clearances in the Dental panel. Data: openFDA.