Skip to content

Softek Ent.

Country not established

Devices
1

What Softek Ent. makes

Softek Ent. manufactures the Tongue Clean, a Class I medical device designed for oral hygiene, specifically for cleaning the tongue surface to reduce bacteria and improve freshness.

The Tongue Clean is regulated under FDA 510(k) clearance as a Class I device and is listed in the U.S. regulatory database. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Tongue Klean Ref K973175

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Softek Ent. have in the registry?

The registry currently lists 1 device for Softek Ent.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Softek Ent.'s devices?

Among its 1 most recently registered device, Softek Ent. has devices listed in FDA 510(k) (1 device).

What risk classes do Softek Ent.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Softek Ent.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Softek Ent. in the registry?

The most recently registered devices listed for Softek Ent. include TONGUE KLEAN.

Generated automatically from registry data and not verified by a human reviewer.