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Perma-Cryl 20

by Coe Laboratories, Inc.

510(k) K792427

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 NumberK792427 Date13 Dec 1979ClearedStatusActive

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  • Withdrawn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
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Perma-Cryl 20 is a dental device classified as a resin for crown and bridge applications, intended for use in dental procedures. It is designed to provide durable and aesthetic restorations in the dental field.

The device is supplied as a single-use item and is not reusable. It is not specified as sterile, and no storage conditions are provided. The device has received FDA 510(k) clearance under K792427, with a decision of Substantially Equivalent.

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Questions

AI-generated answers, 25 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 Perma-Cryl 20 used for?

    Perma-Cryl 20 is a dental resin designed for use in crown and bridge applications. It is intended to provide durable and aesthetic restorations in dental procedures.

  • Is Perma-Cryl 20 sterile?

    No, the device is not specified as sterile. It is supplied as a single-use item and is not intended for reuse.

  • How is Perma-Cryl 20 supplied?

    Perma-Cryl 20 is supplied as a single-use item. It is not reusable and is intended for use in dental procedures.

  • What is the regulatory status of Perma-Cryl 20?

    Perma-Cryl 20 has received FDA 510(k) clearance under K792427, with a decision of Substantially Equivalent.