Thommen Medical

Also known as: Thommen Medical AG

An independent, family-owned Swiss manufacturer of dental implants based in Grenchen, producing the SPI implant system since 1975.

Key facts

Country	SwitzerlandVerified spec[1]
Headquarters	Grenchen, SwitzerlandVerified spec[1]
Founded	1975Verified spec[1]
Ownership	Described as an independent family businessManufacturer-reported[1]
manufacturingCountry	SwitzerlandVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Thommen Medical is a Swiss manufacturer in Grenchen that has made implants since 1975 and remains an independently held family business, which places it outside the acquisition trail that consolidated much of the industry. Its implants are sold under the SPI name across three lines — ELEMENT, CONTACT and NEVO — that share a common surgical procedure. Ownership stability is worth noting for long-term parts supply, but it is not by itself evidence about clinical outcomes.

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) clearance9 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K171795	Thommen Implant System	Thommen Medical AG	2017-09-29
K093615	SPI DENTAL IMPLANT, ELEMENT	Thommen Medical AG	2010-03-04
K090154	SPI DENTAL IMPLANT INICELL	Thommen Medical AG	2009-07-27
K072649	SPI SYSTEM DENTAL IMPLANTS	Thommen Medical AG	2007-12-06
K072933	SPI CONTACT PLATFORM O 4.0 MM	Thommen Medical AG	2007-11-15
K070007	SPI ELEMENT PLATFORM O 4.0 MM	Thommen Medical AG	2007-01-10
K051502	SPI DENTAL IMPLANT	Thommen Medical AG	2005-06-21
K034014	SPI CONTACT DENTAL IMPLANT	Thommen Medical AG	2004-03-05
K030689	SPI ELEMENT DENTAL IMPLANT O 3.5 MM	Thommen Medical AG	2003-03-26

Other2 records

Registered device establishment in Switzerland. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

Number	Device	Holder	Date
3003184527	—	THOMMEN MEDICAL, AG	—
243 device records	—	Thommen Medical	—

Clearance records for Thommen Medical 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 Thommen Medical.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]About us — Thommen Medical — Thommen Medical AG. Accessed 2026-07-22.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.