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OptraGate 2 Assortment

by Ivoclar Vivadent AG

Ref 757915WW

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 Number76152081XDAMS001US Basic UDI-DI 07615208516982UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208516982 UDI-DI Date21 Feb 2025ListedStatusListed 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  • Withdrawn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
OptraGate 2 Assortment EUDAMED
OptraGate 2 GUDID
Generic Name
Dental cheek retractor, professional, single-use
Device Name
OptraGate, OptraGate 2, GBT Visigate
Model / Ref / Catalog
757915WW
Primary DI / UDI-DI
07615208516982
Basic UDI-DI
76152081XDAMS001US
Unit of Use DI
07615208535907
FDA Product Code
EIF
EMDN Code
Q019002 Dentistry dams and hooks, single-use
GMDN Term
Dental cheek retractor, professional, single-use
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
LI-MF-000000522

Other devices from Ivoclar Vivadent AG

See all devices from Ivoclar Vivadent AG →

Properties

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

Other properties (18)

  • 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