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Remin Pro 2004

by VOCO GmbH

Ref 2004

Remin Pro 2004 is a Class I device made by VOCO GmbH, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-E22120041), cleared under FDA 510(k) K101104 on 21 Oct 2010 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22120041), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101104

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-E22120041 Basic UDI-DI E22120041UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22120041 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101104 Date21 Oct 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-E22120041 registered 1 Oct 2026 Active
  • FDA 510(k) K101104 decided 21 Oct 2010 Active
  • FDA GUDID UDI-DI E22120041 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101104
  2. Listed FDA GUDID E22120041
  3. Registered EUDAMED B-E22120041

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  • Withdrawn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
Remin Pro
Generic name
Dentifrice
Model / Ref / Catalog
2004
Primary DI / UDI-DI
E22120041
Basic UDI-DI
B-E22120041
510(k) Number
FDA product code
EJR
EMDN code
Q019008 Dentinal desensitisers
GMDN term
Dentifrice
Device class
Class I
Regulation number
872.6030
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dentifrice

Cleared under the same submission (K101104)

and 1 more cleared under K101104

Similar devices in this category

Other devices filed under DENTINAL DESENSITISERS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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