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STERI-OSS

by Denar Corp. 510(k)

Active United States

510(k) K884845

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884845 Date10 Feb 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 23 Sep 2026

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

STERI-OSS is a dental device classified under product code DZE. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device was manufactured by Denar Corp. and received FDA 510(k) clearance on February 10, 1989, under k-number K884845. It is authorized for sale in the United States.

Other devices from Denar Corp.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the STERI-OSS device used for?

    The STERI-OSS device is used in dental applications, but its specific use is not detailed in the provided information.

  • Is the STERI-OSS device authorized for sale in the US?

    Yes, the STERI-OSS device received FDA 510(k) clearance on February 10, 1989, and is authorized for sale in the United States.

  • What is the product code for the STERI-OSS device?

    The STERI-OSS device is classified under product code DZE.