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Ortolux Top Anterior Teeth 65/2N

by Union Dental SA

Ref D3652NModel Artificial Teeth

Ortolux Top Anterior Teeth 65/2N (D3652N) is a device classified as Class IIa in the EU and Class II in the US made by Union Dental SA, registered in EUDAMED on 2 Nov 2022 (Basic UDI-DI 084352884UD-TEETHVS), cleared under FDA 510(k) K070591 on 11 May 2007 and listed in FDA GUDID since 16 Sep 2024 (UDI-DI 08435288438085), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K070591

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08435288438085 UDI-DI Date16 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number084352884UD-TEETHVS Basic UDI-DI 08435288438085UDI-DIDate2 Nov 2022RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK070591 Date11 May 2007IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084352884UD-TEETHVS registered 2 Nov 2022 Active
  • FDA 510(k) K070591 decided 11 May 2007 Active
  • FDA GUDID UDI-DI 08435288438085 listed 16 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K070591
  2. Registered EUDAMED 084352884UD-TEETHVS
  3. Listed FDA GUDID 08435288438085

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ortolux Top
Generic name
Resin artificial teeth
Model / Ref / Catalog
Artificial Teeth, D3652N, ANTERIOR TEETH 65/2N
Primary DI / UDI-DI
08435288438085
Basic UDI-DI
084352884UD-TEETHVS
510(k) Number
FDA product code
ELM
EMDN code
Q01020601, Q01020602, Q01020603, Q01020605
GMDN term
Resin artificial teeth
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3590
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Artificial Teeth
D3652N
GUDID
ANTERIOR TEETH 65/2N
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Resin artificial teeth

Cleared under the same submission (K070591)

and 8 more cleared under K070591

Other devices from Union Dental SA

See all devices from Union Dental SA →

Properties

  • Single use
  • Lot / batch number
Other properties (23, all answered No)