Thommen SPI

Also known as: Thommen, SPI, Thommen Medical

The Swiss dental implant brand of Thommen Medical, comprising the ELEMENT, CONTACT and NEVO implant lines.

Key facts

Manufacturer	Thommen Medical AGVerified spec[1]
Country	SwitzerlandVerified spec[1]
Manufacturer-described indication	SPI implant system offered in three lines — ELEMENT, CONTACT and NEVO — that share one surgical procedureManufacturer-reported[2]
manufacturingCountry	SwitzerlandVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Thommen SPI is the implant brand of the independent Swiss maker Thommen Medical, in production since 1975. The range is organised into three lines — ELEMENT, CONTACT and NEVO — which are designed to share a single surgical protocol, so a clinic can move between them without relearning the surgery. Thommen sits in the premium Swiss tier alongside Straumann; that is a market position, and clinical questions are answered separately by studies rather than by country of origin.

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) clearance2 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
K151984	Thommen Milling Abutment for CAD/CAM	Thommen Medical AG	2016-03-10

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 SPI	—

Clearance records for Thommen SPI 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 SPI.

Sources

Numbers match the citations beside each claim above.

Primary sources

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