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Coltosol F 5935

by Coltène/Whaledent AG

Ref 5935Model Coltosol F

Coltosol F 5935 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 22 Oct 2026 (Basic UDI-DI B-J00659350), cleared under FDA 510(k) K031752 on 5 Aug 2003 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00659350), 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) K031752

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-J00659350 Basic UDI-DI J00659350UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ00659350 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031752 Date5 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-J00659350 registered 22 Oct 2026 Active
  • FDA 510(k) K031752 decided 5 Aug 2003 Active
  • FDA GUDID UDI-DI J00659350 listed 15 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031752
  2. Listed FDA GUDID J00659350
  3. Registered EUDAMED B-J00659350

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  • Withdrawn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
Coltosol F Sample Syr. 8g EUDAMED
Coltosol F GUDID
Generic name
Zinc phosphate dental cement
Model / Ref / Catalog
5935, Coltosol F
Primary DI / UDI-DI
J00659350
Basic UDI-DI
B-J00659350
510(k) Number
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
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 · 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: Zinc phosphate dental cement

Cleared under the same submission (K031752)

and 2 more cleared under K031752

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)