Data / Medical devices / Facebow
Facebow (KCR): 33 FDA-registered makers in 11 countries
33 establishments in 11 countries are registered with the FDA to make Facebow (product code KCR, Class 1, 21 CFR 872.3220). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 28, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCR
- Device class
- 1
- Regulation
- 872.3220
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 6 |
| China | 5 |
| United States | 4 |
| Austria | 3 |
| Brazil | 3 |
| Germany | 3 |
| South Korea | 3 |
| Italy | 2 |
| Japan | 2 |
| Sweden | 1 |
| Liechtenstein | 1 |
Makers of Facebow
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Dental Designs | Moreno Valley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asa Dental S.P.A. | MARLIA Lucca, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Astar Orthodontics Inc. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avilign Medical | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amann Girrbach AG | Maeder Vorarlberg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Art Equipamentos Odontologicos Ltda. | SAO CARLOS Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Central Surgical Co. Pvt. Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Morelli Ltda. | SOROCABA Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forestadent Bernhard Forster GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gamma Medizinisch Wissenschaftliche Fortbildungsge | KLOSTERNEUBURG Niederosterreich, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Cheer-U Material Technology Co., Ltd | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Pengwu Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IVOCLAR VIVADENT Manufacturing GmbH | BURS Vorarlberg, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacigrus International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neobiotech Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthodontic Manufacturer Sia SRL | ROCCA D EVANDRO Caserta, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PNUAdd Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sam Prazisionstechnik GMBH | Gauting Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seilglobal Co., Ltd | Busan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shioda Dental Corporation | NASU-KARASUYAMA Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sitec (pvt.) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnident Equipamentos Ortodonticos Ltda. | SAO CARLOS Sao Paulo, Brazil | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomy, Inc. | Iwaki City Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volgo Care International (private) Limited | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whip-Mix Corp. | Louisville, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Lab U.S.A. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Risheng Medical Technology Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 28, 1983. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.