Skip to content

AlignerFlow LC

by VOCO GmbH

Ref 1526, 1528, 1527, 1529

AlignerFlow LC (1526) is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E22100250000000008G), cleared under FDA 510(k) K231817 on 1 Dec 2023 and listed in FDA GUDID since 6 Dec 2023 (UDI-DI E22115261), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K231817↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E22100250000000008G Basic UDI-DI Date30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22115261 UDI-DI Date6 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK231817 Date1 Dec 2023IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E22100250000000008G registered 30 Mar 2026 Active
  • FDA 510(k) K231817 decided 1 Dec 2023 Active
  • FDA GUDID UDI-DI E22115261 listed 6 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231817
  2. Listed FDA GUDID E22115261
  3. Registered EUDAMED ++E22100250000000008G

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Dental composite resin
Model / Ref / Catalog
1526, 1527, 1529, 1528
Primary DI / UDI-DI
E22115261, E22115271, E22115291, E22115281
Basic UDI-DI
++E22100250000000008G
510(k) Number
FDA product code
DYH
EMDN code
Q0101010201 Dental base cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3750
EU registration type
Standard device
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

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.

Manufacturer details

EUDAMED SRN
DE-MF-000008601

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL BASE CEMENTS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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