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TEMREX LIQUID 310 1oz.

by Temrex Corp.

Ref 310-330

TEMREX LIQUID 310 1oz. (310 1oz.) is a device classified as Class I in the EU and Class II in the US made by Temrex Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00850015110023) and listed in FDA GUDID since 13 Feb 2020 (UDI-DI 00850015110023), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850015110023 Basic UDI-DI 00850015110023UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850015110023 UDI-DI Date13 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850015110023 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00850015110023 listed 13 Feb 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850015110023
  2. Registered EUDAMED B-00850015110023

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Temrex Cement Liquid EUDAMED
Temrex Liquid GUDID
Generic name
Zinc oxide eugenol dental cement
Model / reference
310-330 EUDAMED
310 1oz. GUDID
Primary DI / UDI-DI
00850015110023
Basic UDI-DI
B-00850015110023
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
GMDN term
Zinc oxide eugenol dental cement
Device class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
310-330
GUDID
310 1oz.
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Zinc oxide eugenol dental cement

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)