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DC Provi Cem Esthetic, Esthetic Multi F, Implant

by S & C Polymer GmbH

510(k) K091735

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 NumberK091735 Date25 Sep 2009ClearedStatusActive

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  • Withdrawn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, 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.

This device is a dental cement system comprising three variants: DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F, and DC Provi Cem Implant. It is intended for cementing temporary restorations such as crowns, bridges, inlays or onlays, as well as for trial cementing of permanent restorations and for cementing of semi-permanent implants.

The device is supplied by S & C Polymer GmbH and has received FDA 510(k) clearance under K091735. It is classified as a Class II dental cement device and is used by dental professionals in clinical settings. The product is non-sterile and intended for single-use application in dental procedures.

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