Skip to content

Multi-Prime Aka/Mono-Prime

by Silicon-Und Composite Spezialitaten GmbH

510(k) K953476

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 NumberK953476 Date22 Sep 1995ClearedStatusActive

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  • Withdrawn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
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Multi-Prime Aka/Mono-Prime is a dental device, classified as a tooth bonding resin agent. It is designed for use in dental applications.

The device is supplied as a single product and is regulated under FDA 510K with a clearance type of Traditional. It has a product code of KLE and a regulation number of 872.3200. The device was found to be substantially equivalent and was cleared on September 22, 1995.

Other devices from Silicon-Und Composite Spezialitaten GmbH

  • Prov-Kb

    Class II

  • Etching Gel

    Class II

  • Tray-Link

    Class II