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Lichthärtendes Material zur Herstellung dentaler Schienen mittels 3D-Druckverfahren

by Dreve Dentamid GmbH

Ref D36150

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2390056YH Basic UDI-DI +E239D361501UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E239D361501 UDI-DI Date25 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Primeprint Direct Aligner
Generic Name
Orthodontic progressive aligner
Device Name
Lichthärtendes Material zur Herstellung dentaler Schienen mittels 3D-Druckverfahren
Model / Ref / Catalog
D36150
Primary DI / UDI-DI
+E239D361501 EUDAMED
E239D361501 GUDID
Basic UDI-DI
++E2390056YH
510(k) Number
FDA Product Code
NXC
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Orthodontic progressive aligner
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.5470
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E239D361501
GUDID
E239D361501
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005452

Other devices from Dreve Dentamid GmbH

See all devices from Dreve Dentamid GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No