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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

ManufacturerEnvista Holdings CorporationVerified spec[1][2][3]
Parent companyEnvista Holdings Corporation, Brea, CaliforniaVerified spec[1]
CountryIsrael — Envista reports a production facility in Israel for the Alpha-Bio Tec implant brandVerified spec[1]
HeadquartersManufacturer documentation not located(The brand’s own corporate page does not state a headquarters address)
FoundedManufacturer documentation not located(No founding date is given on the manufacturer pages we were able to reach)
OwnershipOwned by Envista Holdings and operated as one of its value implant businessesVerified spec[1][2]
Manufacturer-described indicationPresented by Envista as specialising in cost-effective implantology solutionsManufacturer-reported[3]

Overview

Alpha-Bio Tec is one of two value implant brands Envista runs alongside Nobel Biocare, the other being Implant Direct. Envista is explicit in its own filings that these are value businesses covering different price points, so an Alpha-Bio Tec implant is not a differently badged Nobel Biocare one, and the components do not interchange. Manufacturing is in Israel. We hold this record as database-only because the brand’s own pages do not give a founding date or a headquarters address, and we would rather show those as unknown than fill them from secondary summaries.

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.

NumberDeviceHolderDate
K063364ALPHA BIO DENTAL IMPLANT SYSTEMAlpha-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

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