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DuraLock® PLUS Impression Trays

by Ortho Organizers, Inc. EUDAMEDGUDID

Active European Union

Ref 640-043

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190707O2ImpressionTrayC8 Basic UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00190707099329 UDI-DIDate6 Jan 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Dental impression tray, reusable
Device Name
Dental Impression Material Trays
Model / Reference
640-043
Primary DI / UDI-DI
00190707099329
Basic UDI-DI
0190707O2ImpressionTrayC8
Unit of Use DI
10190707099326
FDA Product Code
EHY
EMDN Code
Q010503 Impression material trays, single-use
GMDN Term
Dental impression tray, reusable
Device Class
Class I
Regulation Number
872.6880
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000010061
Authorised representative
mdi Europa GmbH DE-AR-000006218

Related devices

Category: Dental impression tray, single-use

Other devices from Ortho Organizers, Inc.

See all devices from Ortho Organizers, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No