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Compolute Aplicap

by Espe Dental-Medizin GmbH & Co.Kg.

510(k) K974458

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 NumberK974458 Date2 Feb 1998ClearedStatusActive

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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Compolute Aplicap is a dental cement device used for dental applications. It is classified as a Class II dental cement under product code EMA.

The device is supplied by Espe Dental-Medizin GmbH & Co.Kg. and received FDA 510(k) clearance on February 2, 1998, with the decision code SESE (Substantially Equivalent). It is regulated under number 872.3275.

Questions

AI-generated answers, 28 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 Compolute Aplicap used for?

    Compolute Aplicap is a dental cement device specifically designed for dental applications. It is classified as a Class II dental cement under product code EMA, indicating its intended use in dental procedures.

  • How is the Compolute Aplicap supplied?

    The Compolute Aplicap is supplied by Espe Dental-Medizin GmbH & Co.Kg. The device is manufactured in Bavaria, Germany, and distributed for dental applications. The specific packaging details are not provided in the available information.

  • What is the regulatory status of the Compolute Aplicap?

    The Compolute Aplicap received FDA 510(k) clearance on February 2, 1998, with the decision code SESE (Substantially Equivalent). It is regulated under number 872.3275 as a Class II dental cement device.

  • Is the Compolute Aplicap single-use or reusable?

    The available information does not specify whether the Compolute Aplicap is designed for single-use or reusable applications. This detail would typically be found in the device's instructions for use, which are not provided in the current data.