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STERI-OSS Implant System

by Zeros Co., Ltd.

510(k) K232268

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 NumberK232268 Date25 Mar 2024ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA product code
DZE
Device class
Class II
Regulation
21 CFR Part 872.3640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 STERI-OSS Implant System is a dental device substantially equivalent to a predicate device, as determined by FDA 510(k) clearance. It is classified under product code DZE and reviewed by the Dental advisory committee (DE).

The device is manufactured by Zeros Co., Ltd. and received FDA 510(k) clearance via the traditional pathway on March 25, 2024, with application number K232268. It is supplied as a single unit and is not indicated for MRI safety or sterility status in the provided data.

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