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Protec-Top, Sterident, Bento

by Ronpak, Inc.

510(k) K031022

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 · Special NumberK031022 Date14 Apr 2003ClearedStatusActive

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  • Withdrawn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, 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.

PROTEC-TOP, STERIDENT, BENTO is a sterilization wrap used by healthcare facilities to package medical items for sterilization and subsequent sterile storage. The device incorporates a chemical indicator imprint that changes color from green to blue-gray upon exposure to sterilization processes.

The device is supplied as a wrap and is used in general hospital settings. It is intended for steam, chemical vapor, or dry heat sterilization processes. The device has FDA 510(k) clearance with product code FRG and was determined to be substantially equivalent.

Questions

AI-generated answers, 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.

  • What is the PROTEC-TOP sterilization wrap used for?

    PROTEC-TOP is a sterilization wrap used by healthcare facilities to package medical items for sterilization and subsequent sterile storage. It incorporates a chemical indicator that changes color from green to blue-gray when exposed to sterilization processes.

  • What types of sterilization processes is the PROTEC-TOP wrap compatible with?

    The PROTEC-TOP wrap is intended for use with steam, chemical vapor, or dry heat sterilization processes in general hospital settings.

  • How is the PROTEC-TOP sterilization wrap supplied?

    The device is supplied as a wrap specifically designed for packaging medical items that require sterilization and sterile storage.

  • What regulatory status does the PROTEC-TOP sterilization wrap have?

    The PROTEC-TOP sterilization wrap has FDA 510(k) clearance with product code FRG and was determined to be substantially equivalent.