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OpalDam

by Ultradent Products, Inc. 2 variants

Ref 324-U

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K971284↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00883205029133 UDI-DI Date22 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0883205-TF279BU Basic UDI-DI 00883205029133UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK971284 Date3 Jun 1997IssuedStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Rubber dam, non-latex
Device Name
OpalDam, OpalDam Green
Model / Ref / Catalog
324-U
Primary DI / UDI-DI
00883205029133
Basic UDI-DI
0883205-TF279BU
FDA Product Code
EIG
EMDN Code
Q019002 Dentistry dams and hooks, single-use
GMDN Term
Rubber dam, non-latex
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000013697
Authorised representative
Ultradent Products GmbH DE-AR-000006666

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No