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FRIALIT-2 3.4MM Steeped Cylinder Implant With Frios TPS Coating; Frios HA

by Friadent GmbH

510(k) K994376

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994376 Date24 Mar 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Frialit-2 3.4mm Steeped Cylinder Implant with Frios Tps Coating; Frialit-2 3.4mm Steeped Cylinder Implant with Frios Ha
510(k) Number
FDA Product Code
DZE
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Frialit-2 3.4mm Steeped Cylinder Implant is an endosseous, root-form dental implant designed for osseointegration within the jawbone. It features a stepped cylinder geometry and is available with two distinct coatings: Frios TPS (titanium plasma sprayed) and Frios HA (hydroxylapatite). These coatings enhance surface properties to improve integration and stability during bone healing.

This implant is supplied as a single-use, sterile device intended for surgical placement by dental professionals. It is classified under FDA product code DZE and holds a 510(k) clearance for dental applications. The device is non-magnetic and intended for use in non-MRI environments. Storage requires adherence to manufacturer guidelines to maintain sterility and integrity prior to use.

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