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Micron Luting 15g

by Prevest Denpro Limited

Ref 30011Model Dental Cements

Micron Luting 15g (30011) is a device classified as Class IIa in the EU and Class II in the US made by Prevest Denpro Limited, registered in EUDAMED on 8 Aug 2026 (Basic UDI-DI B-+D967300110_), cleared under FDA 510(k) K200555 on 13 May 2021 and listed in FDA GUDID since 12 Dec 2022 (UDI-DI +D967300110_), 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) K200555

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-+D967300110_ Basic UDI-DI +D967300110_UDI-DIDate8 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D967300110_ UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200555 Date13 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+D967300110_ registered 8 Aug 2026 Active
  • FDA 510(k) K200555 decided 13 May 2021 Active
  • FDA GUDID UDI-DI +D967300110_ listed 12 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200555
  2. Listed FDA GUDID +D967300110_
  3. Registered EUDAMED B-+D967300110_

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  • Withdrawn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
Micron Luting
Generic name
Glass ionomer dental cement
Model / Ref / Catalog
Dental Cements, 30011, 15g
Primary DI / UDI-DI
+D967300110_ EUDAMED
D967300110 GUDID
Basic UDI-DI
B-+D967300110_
510(k) Number
FDA product code
EMA
EMDN code
Q01010106 Dental restoration glass ionomers
GMDN term
Glass ionomer 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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Dental Cements
30011
GUDID
15g
Primary DI / UDI-DIEUDAMED
+D967300110_
GUDID
D967300110
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D967300110_; FDA GUDID lists D967300110), so their flags are not compared. 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: Glass ionomer dental cement

Cleared under the same submission (K200555)

and 7 more cleared under K200555

Similar devices in this category

Other devices filed under DENTAL RESTORATION GLASS IONOMERS.

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)