Data / Medical devices / Handpiece, Belt And/Or Gear Driven, Dental
Handpiece, Belt And/Or Gear Driven, Dental (EFA): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Handpiece, Belt And/Or Gear Driven, Dental (product code EFA, Class 1, 21 CFR 872.4200). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on August 25, 2020, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EFA
- Device class
- 1
- Regulation
- 872.4200
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| United States | 2 |
| Japan | 2 |
| South Korea | 2 |
| Austria | 2 |
| France | 1 |
Makers of Handpiece, Belt And/Or Gear Driven, Dental
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 |
|---|---|---|---|---|---|---|---|---|
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 3 | March 3, 2010 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 2 | March 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Complaint file establishment, Manufacturer | 2 | August 25, 2006 | 0 | 0 | 0 | api.fda.gov |
| DPM Usa Corp. | Doral, FL, United States | Manufacturer | 1 | October 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 1 | August 25, 2006 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp., Tottori Factory | Kurayoshi Tottori, Japan | Manufacturer | 1 | August 25, 2006 | 0 | 0 | 0 | api.fda.gov |
| Micro-Nx Co., Ltd. | Dong-gu Daegu, South Korea | Manufacturer | 1 | August 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | September 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 25, 2020. 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.