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Steri-Dent, Steri-Sure

by Cpac, Inc. 2 variants

510(k) K110867

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 NumberK110867 Date20 Jul 2011ClearedStatusActive

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  • Withdrawn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
FRG
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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-Dent, Steri-Sure is a sterilization wrap designed to facilitate the sterilization of medical instruments. It is intended for use in a dry heat sterilizer operating at 160°C for 60 minutes and serves to maintain the sterility of the enclosed instruments for up to 30 days following the process.

This device is supplied as a self-seal nylon pouch. It has received FDA 510(k) clearance under the product code FRG and is classified as a Class II medical device.

Other devices from Cpac, Inc.