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ClearTemp LC 3518

by Ultradent Products, Inc.

Ref 3518

ClearTemp LC 3518 is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI B-00883205106674), cleared under FDA 510(k) K111017 on 6 Jun 2011 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205106674), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111017

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00883205106674 Basic UDI-DI 00883205106674UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205106674 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111017 Date6 Jun 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00883205106674 registered 29 Jun 2026 Active
  • FDA 510(k) K111017 decided 6 Jun 2011 Active
  • FDA GUDID UDI-DI 00883205106674 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111017
  2. Listed FDA GUDID 00883205106674
  3. Registered EUDAMED B-00883205106674

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ClearTemp LC
Generic name
Dental composite resin
Model / Ref / Catalog
3518
Primary DI / UDI-DI
00883205106674
Basic UDI-DI
B-00883205106674
510(k) Number
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Cleared under the same submission (K111017)

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)