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Opal Bond 500037

by Ultradent Products, Inc.

Opal Bond 500037 is a Class I device made by Ultradent Products, Inc., listed in FDA GUDID since 16 Jun 2018 (UDI-DI 00883205015280), 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 Number00883205015280 UDI-DI Date16 Jun 2018ListedStatusListed 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  • Withdrawn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
Opal Bond
Generic name
Orthodontic bracket adhesive
Model / Ref / Catalog
500037
Primary DI / UDI-DI
00883205015280
FDA product code
DZN
GMDN term
Orthodontic bracket adhesive
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket adhesive

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)