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Opalpix 5590

by Ultradent Products, Inc. 2 variants

Opalpix 5590 is a Class I device made by Ultradent Products, Inc., listed in FDA GUDID since 23 May 2017 (UDI-DI 00883205004772), 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 Number00883205004772 UDI-DI Date23 May 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  • Withdrawn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
Opalpix
Generic name
Periodontal pick/brush, reusable
Model / Ref / Catalog
5590
Primary DI / UDI-DI
00883205004772
FDA product code
JET
GMDN term
Periodontal pick/brush, reusable
Device class
Class I
Regulation number
872.6650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Periodontal pick/brush, reusable

Similar devices

Other devices filed under FDA product code JET (PICK, MASSAGING).

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)