Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 28
- Latest Decision
- 2025-11-18
Clearances · page 3 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | 2025-11-18 |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | MUH | Class II | 2025-11-10 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | JEY | Class II | 2025-11-07 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | EBF | Class II | 2025-11-07 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | DZE | Class II | 2025-11-07 |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | NXC | Class II | 2025-11-07 |
| K252525 | AIO Breathe | Aiomega, LLC | LRK | Class II | 2025-11-06 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | KLE | Class II | 2025-11-06 |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | LRK | Class II | 2025-11-03 |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | EIA | Class I | 2025-11-03 |
| K251547 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2025-10-31 |
| K253501 | 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); | Vigodent Indústria E Comercio Ltda | ELW | Class II | 2025-10-31 |
| K252430 | Freeprint® denture flex | Detax GmbH | EBI | Class II | 2025-10-30 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | 2025-10-30 |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | LRK | Class II | 2025-10-29 |
| K252376 | Yomi S Robotic System | Neocis, Inc. | PLV | Class II | 2025-10-28 |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | EMA | Class II | 2025-10-28 |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | LRK | Class II | 2025-10-24 |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | MUH | Class II | 2025-10-24 |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2025-10-23 |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | NXC | Class II | 2025-10-23 |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | LRK | Class II | 2025-10-22 |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | NHA | Class II | 2025-10-17 |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | NHA | Class II | 2025-10-17 |
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | EKX | Class I | 2025-10-16 |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2025-10-16 |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | NHA | Class II | 2025-10-15 |
| K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | NHA | Class II | 2025-10-15 |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | EBZ | Class II | 2025-10-14 |
| K251835 | Yomi Robotic System | Neocis, Inc. | PLV | Class II | 2025-10-10 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | DZE | Class II | 2025-10-10 |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | NXC | Class II | 2025-10-09 |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | LRK | Class II | 2025-10-03 |
| K251124 | G-Bond Universal | GC America, Inc. | KLE | Class II | 2025-10-02 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | EBF | Class II | 2025-09-29 |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | DZL | Class II | 2025-09-29 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | DZE | Class II | 2025-09-29 |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | 2025-09-26 |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | DZE | Class II | 2025-09-25 |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | KIF | Class II | 2025-09-25 |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | MUH | Class II | 2025-09-24 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBF | Class II | 2025-09-23 |
| K252285 | Well-Root PT | Vericom Co., Ltd. | KIF | Class II | 2025-09-19 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | ELC | Class II | 2025-09-19 |
| K250953 | EQUIA LC ONE | GC America, Inc. | EMA | Class II | 2025-09-19 |
| K251597 | InnerView System | Perimetrics, Inc. | EKX | Class I | 2025-09-18 |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | LYC | Class II | 2025-09-17 |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | EBI | Class II | 2025-09-17 |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | LRK | Class II | 2025-09-17 |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | NHA | Class II | 2025-09-16 |
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | EGS | Class I | 2025-09-15 |
| K251758 | Serafin® | Tns Co., Ltd. | NXC | Class II | 2025-09-11 |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | LRK | Class II | 2025-09-11 |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | EHD | Class II | 2025-09-04 |
| K250353 | Oniris; Oniris Plus | Oniris | LRK | Class II | 2025-09-04 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | 2025-09-03 |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | EMA | Class II | 2025-09-02 |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | NHA | Class II | 2025-09-02 |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | LYC | Class II | 2025-08-29 |
| K252380 | Invisalign System | Align Technology, Inc. | NXC | Class II | 2025-08-29 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | EBF | Class II | 2025-08-29 |
| K250771 | Primescan 2 | Dentsply Sirona, Inc. | NTK | Class II | 2025-08-29 |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | NXC | Class II | 2025-08-27 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | EBW | Class I | 2025-08-25 |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | DZE | Class II | 2025-08-25 |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | EIH | Class II | 2025-08-25 |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | KIF | Class II | 2025-08-22 |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | EKX | Class I | 2025-08-22 |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. | DZE | Class II | 2025-08-21 |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | NHA | Class II | 2025-08-20 |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2025-08-20 |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | DZE | Class II | 2025-08-18 |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL | Class II | 2025-08-14 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | DZL | Class II | 2025-08-13 |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | 2025-08-13 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | DZE | Class II | 2025-08-12 |
| K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | EBC | Class II | 2025-08-08 |
| K243427 | QuickSleeper 5 | Dentalhitec | EGM | Class II | 2025-08-01 |
| K241183 | ISO Abutment | Seum Medi Co., Ltd. | NHA | Class II | 2025-07-28 |
| K251220 | NUVENTUS NV.C Prosthetic Components | Infinitum Eta, Ltd. | NHA | Class II | 2025-07-28 |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | DZE | Class II | 2025-07-24 |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2025-07-23 |
| K251280 | DESS® Dental Implants | Terrats Medical SL | DZE | Class II | 2025-07-23 |
| K251616 | Clear Miracle | Ods Co., Ltd. | NXC | Class II | 2025-07-22 |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | EBW | Class I | 2025-07-18 |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | EIA | Class I | 2025-07-17 |
| K250156 | Choice 2 DC | Bisco, Inc. | EMA | Class II | 2025-07-11 |
| K251470 | ResiCem EX | Shofu Dental Corporation | EMA | Class II | 2025-07-11 |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | NPM | Class II | 2025-07-11 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | EIH | Class II | 2025-07-10 |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | DZE | Class II | 2025-07-09 |
| K251390 | MTA vpt | Voco GmbH | KIF | Class II | 2025-07-03 |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | DZE | Class II | 2025-07-03 |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | ELW | Class II | 2025-06-27 |
| K251660 | T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC | DZE | Class II | 2025-06-27 |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | DZL | Class II | 2025-06-27 |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | EIA | Class I | 2025-06-27 |
| K251613 | SwissGraft X | Geistlich Pharma AG | NPM | Class II | 2025-06-26 |
| K250967 | Sherlock | Open Implants, LLC | NHA | Class II | 2025-06-26 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | 2025-06-25 |
12,679 clearances in the Dental panel. Data: openFDA.