Data / Medical devices / Israel / BHI Implants
BHI Implants: FDA-registered device maker in Afula Northern, Israel, 1 510(k) clearance
BHI Implants is registered with the FDA (registration 3010393542) in Afula Northern, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010393542
- Address
- Hamal 2, Afula Northern, Israel, 1857107
- Owner or operator
- BHI Implant l Ltd. (10044723)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 18, 2013
- Registered through
- 2026
- Brand names listed
- A3824, A5024, ABA1801, ABA1802, ABA1803, ABA3001, ABA3002, ABA3003 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2011 | K103280 | BHDENTAL IMPLANT SYSTEM | NHA | Substantially Equivalent | Bhdental, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
Updated February 24, 2011. 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.