The dental device directory · FDA data as of 2 Nov 2026
Who makes what in dentistry.
3,592 companies registered with FDA, the 330 device types they list, 96,725 brand and model names, and where each company is registered across 29 markets.
Start withdental implantsintraoral scannersclear alignersmakers in South Korea
Find the makers of a device
Each category lists every company that registers that device with FDA, the brands and models they list, and the clearances behind them.
One company, every market
2,406 of these companies are named in a device registry outside the United States, 786 of them in five or more. Open a company to see its map.
Every category
number of makers registered with FDAImplantology
Digital dentistry & imaging
Operatory equipment
Restorative materials
Prosthodontics & lab
Orthodontics
Oral & maxillofacial surgery
Instruments & consumables
Latest FDA clearances
All clearances| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 30 Oct 2026 | K263860 | Shining3D Clear Aligner System | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 30 Oct 2026 | K262685 | Zirconia Collective 4Y Dental Zirconia Blank | Zirconia Collective, Inc. |
| 29 Oct 2026 | K262756 | Zirconia Dental Ceramics and Staining Solution | Fanen New Materials Technology (Suzhou) Co., Ltd. |
| 29 Oct 2026 | K262415 | OSSIX Plus | Datum Dental, Ltd. |
| 29 Oct 2026 | K260356 | EndoColibri | Koehrer Medical Engineering GmbH |
| 27 Oct 2026 | K262775 | AquaVance Clear Fluoride Treatment | The Belport Company, Inc. DBA Gingi-Pak |
| 23 Oct 2026 | K260421 | LuxDesign | LuxCreo Inc. |
| 23 Oct 2026 | K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) | Guangdong JINME Medical Technology Co., Ltd. |
| 22 Oct 2026 | K261295 | MultiNeO Dental Implant System | Alpha-Bio Tec |
| 21 Oct 2026 | K262980 | INNI-CERA (BCM-W500, BCM-W1000) | DentMedi Co., Ltd. |
| 20 Oct 2026 | K262937 | PDR Airway Device | Park Dental Research Corp |
| 20 Oct 2026 | K262421 | Daybreak Impression Material | Sleepcare, LLC |
Most clearances, last five years
| Company | Country | Clearances |
|---|---|---|
| Institut Straumann AG | Switzerland | 34 |
| Dentsply Sirona, Inc. | United States | 27 |
| Prismatik Dentalcraft, Inc. | United States | 23 |
| Terrats Medical, S.L. | Spain | 19 |
| ARUM DENTISTRY Co., Ltd | South Korea | 16 |
| Dentis Co., Ltd. | South Korea | 16 |
| Mediclus Co., Ltd | South Korea | 15 |
| Megagen Implant Co., Ltd. | South Korea | 14 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | 13 |
| Spident Co., Ltd. | South Korea | 13 |
| Align Technology, Inc. | United States | 11 |
| Nakanishi, Inc. | Japan | 11 |
Manufacturers by country
Where the registered establishments are. A group with plants in three countries appears in all three.
How this guide is built
Every company, device type and clearance here comes from three public FDA files: establishment registration and device listing, 510(k) decisions, and product classification. We attach the records to companies with written rules and show the date of the data on every page.
Listing is free and no company pays to appear or to rank. Read the method.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
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