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Ultratemp Temporary Polycarboxylate Cement

by Ultradent Products, Inc.

510(k) K994261

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K994261↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK994261 Date2 Feb 2000ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K994261 decided 2 Feb 2000 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 Ultratemp Temporary Polycarboxylate Cement is a dental cement classified under the nomenclature for dental restorative materials. It is designed as a temporary filling material used in dental procedures to restore teeth following preparations such as cavities or other dental treatments. This cement provides a temporary seal to protect the underlying tooth structure while allowing for the eventual placement of a permanent restoration.

This cement is supplied in a non-sterile, single-use format and is intended for use in clinical dental settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and EU MDR authorization. The product is packaged for dental professionals and must be stored according to manufacturer guidelines to maintain its efficacy. No MRI safety information is specified, and the device is not intended for reusable applications.

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