Skip to content

DuoTEMP 5831

by Coltène/Whaledent AG

Ref 5831Model DUO TEMP

DuoTEMP 5831 is a device classified as Class IIa in the EU and Class II in the US made by Coltène/Whaledent AG, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-J00658310), cleared under FDA 510(k) K072604 on 16 Nov 2007 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00658310), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072604

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-J00658310 Basic UDI-DI J00658310UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ00658310 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072604 Date16 Nov 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-J00658310 registered 26 Oct 2026 Active
  • FDA 510(k) K072604 decided 16 Nov 2007 Active
  • FDA GUDID UDI-DI J00658310 listed 15 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K072604
  2. Listed FDA GUDID J00658310
  3. Registered EUDAMED B-J00658310

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  • Withdrawn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
Duotemp Sgl EUDAMED
DuoTEMP GUDID
Generic name
Zinc phosphate dental cement
Model / Ref / Catalog
5831, DUO TEMP
Primary DI / UDI-DI
J00658310
Basic UDI-DI
B-J00658310
510(k) Number
FDA product code
EMA
EMDN code
Q01010104 Dental bonding agents
GMDN term
Zinc phosphate dental cement
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Zinc phosphate dental cement

Cleared under the same submission (K072604)

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)