Prosthetic devices · 21 CFR 872 Subpart D
Facebow
FDA device type “Facebow”.
- Companies listing it
- 4132 makers
- Brands and models
- 72
- 510(k) clearances
- 10 in five years
- FDA name
- Facebow
510(k) clearances per year, 1976–2026
Companies that list KCR
41 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Ivoclar Vivadent, AG | United States | Maker | Bite Fork · Bite Fork Set · Candulor Registration Set · CRS-10 · +3 | 94 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Maker | SAM Gothic Arch · SmileArch M KIT | 17 | 2024 |
| Amann Girrbach AG | Austria | Maker | Artex facebow · Artex Quickbite · Axis plane pointer with screw · Bite fork partial · +7 | 3 | 2026 |
| Whip Mix Corporation | United States | Maker | Cross Ref · Facebow for dentistry · Facebow general | 8 | 2016 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Facebow | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Seilglobal CO., Ltd | South Korea | Maker | ADD POP BOW | 1 | 2015 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Face bow · Face bows · Face mask · Noninium face bow · +1 | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Facebow | — | — |
| Lacigrus International | Pakistan | Maker | FACEBOW | — | — |
| Dentatus AB | Sweden | Maker | AEB Facebow · AEC Facebow · AEE Facebow · AEK Facebow · +2 | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | FACEBOW · SIA ORTHODONTIC MANUFACTURER | — | — |
| Astar Orthodontics Inc | China | Maker | facebow w/loops · facebow, universal | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Facebow | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | Dental Facebows, Traction Bows | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Facebow, Facebow | — | — |
| PNUAdd Co., Ltd. | South Korea | Maker | ADD POP BOW | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Facebow | — | — |
| ASA Dental | Italy | Maker | Facebow | — | — |
| Avilign Medical | Pakistan | Maker | Facebow | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Elite Facebow · Standard Facebow | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Advanced Dental Designs | United States | Maker | AD2 Anatomic Facebow · Hinge Axis Recorder · Magnetic Mounting System · Precision Mounting Plates | — | — |
| Worldlabusa | United States | Maker | Facebow | — | — |
| Shioda Dental Co. | Japan | Maker | SHIODA | — | — |
| SAM Präzisionstechnik GmbH | Germany | Maker | axioprisa · SAM | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | Face Bow | — | — |
| Gamma Medizinisch Wissenschaftliche Fortbildungsge | Austria | Maker | — | — | — |
| American Orthodontics | United States | Contract manufacturer | 300 Series Facebows | 44 | 2026 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Facebow | 4 | 2004 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | STAR5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Facebow | — | — |
| IDOC Dental Lab | United States | Contract manufacturer | ADD POP BOW | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | FACEBOW | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | DynaFlex FACE BOW | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Bite Plate Facebows · Phoenix Series 100 Facebows | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 Apr 1983 | K830775 | FACEBOW FOR BALANCE ARTICULATOR | Almore Intl., Inc. |
Official records: FDA product classification for KCR · 21 CFR 872.3220.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026