Alpha-Bio Tec
Also known as: Alpha Bio Tec, Alpha-Bio
An Israeli implant brand within Envista Holdings, positioned in the value segment of the implant market.
Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.
Key facts
| Manufacturer | Envista Holdings CorporationVerified spec[1][2][3] |
|---|---|
| Parent company | Envista Holdings Corporation, Brea, CaliforniaVerified spec[1] |
| Country | Israel — Envista reports a production facility in Israel for the Alpha-Bio Tec implant brandVerified spec[1] |
| Headquarters | Manufacturer documentation not located(The brand’s own corporate page does not state a headquarters address) |
| Founded | Manufacturer documentation not located(No founding date is given on the manufacturer pages we were able to reach) |
| Ownership | Owned by Envista Holdings and operated as one of its value implant businessesVerified spec[1][2] |
| Manufacturer-described indication | Presented by Envista as specialising in cost-effective implantology solutionsManufacturer-reported[3] |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance1 record
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K063364 | ALPHA BIO DENTAL IMPLANT SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-14 |
Clearance records for Alpha-Bio Tec were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Alpha-Bio Tec.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Envista Holdings Corporation — Annual Report on Form 10-K for the year ended 31 December 2025 — U.S. Securities and Exchange Commission (EDGAR), 2026. Accessed 2026-07-21.
- [2]Part of Envista Group — Alpha-Bio Tec. — Alpha-Bio Tec. Ltd.. Accessed 2026-07-21.
- [3]Specialty Products & Technology — Envista — Envista Holdings Corporation. Accessed 2026-07-21.