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DuraLock PLUS Impression Trays

by Ortho Organizers, Inc. EUDAMEDGUDID

Active European Union

Ref 501-003U

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190730OTImpressionTrayML Basic UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00190730088857 UDI-DIDate16 Sep 2021ListedStatusListed 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  • Withdrawn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

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
DuraLock PLUS Impression Trays EUDAMED
DuraLock® PLUS GUDID
DuraLock® GUDID
Generic Name
Dental impression tray, single-use
Device Name
Dental Impression Material Trays
Model / Reference
501-003U
Primary DI / UDI-DI
00190730088857, 00190707110833
Basic UDI-DI
0190730OTImpressionTrayML
Unit of Use DI
10190730088854
FDA Product Code
EHY
EMDN Code
Q010503 Impression material trays, single-use
GMDN Term
Dental impression tray, single-use
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

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No