Skip to content

Acrylic Primer

by Lang Dental Manufacturing Company, Inc.

Ref 1602P

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D6500978 Basic UDI-DI D6501602P0UDI-DIDate27 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID NumberD6501602P0 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Acrylic Primer EUDAMED
Acrylic Primer Liquid GUDID
Generic Name
Dental prosthesis restorative material, unfilled resin
Device Name
Denture Reline Acrylic
Model / Ref / Catalog
1602P, 30ML
Primary DI / UDI-DI
D6501602P0
Basic UDI-DI
++D6500978
FDA Product Code
EBI
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental prosthesis restorative material, unfilled resin
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3760
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1602P
GUDID
30ML
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003646
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Lang Dental Manufacturing Company, Inc.

See all devices from Lang Dental Manufacturing Company, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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