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OpalDam 326

by Ultradent Products, Inc.

OpalDam 326 is a rubber dam (FDA Class I; FDA product code EIG, Retractor, All Types) made by Ultradent Products, Inc., listed in FDA GUDID since 23 Dec 2017 (UDI-DI 00883205103512), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205103512 UDI-DI Date23 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OpalDam
Generic name
Rubber dam, non-latex
Model / Ref / Catalog
326
Primary DI / UDI-DI
00883205103512
FDA product code
EIG
GMDN term
Rubber dam, non-latex
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rubber dam, non-latex

Similar devices

Other devices filed under FDA product code EIG (RETRACTOR, ALL TYPES).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)