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Insignia 728-1511

by Ormco Corporation

Insignia 728-1511 is a Class I device made by Ormco Corporation, listed in FDA GUDID since 6 Dec 2022 (UDI-DI 00889989061413), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889989061413 UDI-DI Date6 Dec 2022ListedStatusListed 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  • Withdrawn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
Insignia
Generic name
Orthodontic archwire
Model / reference
728-1511
Primary DI / UDI-DI
00889989061413
FDA product code
DZC
GMDN term
Orthodontic archwire
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic archwire

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)