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Legend 32-1330-0034

by GC Orthodontics America Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD78832133000341 UDI-DI Date29 Mar 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Legend
Generic name
Orthodontic bracket, metal
Model / Ref / Catalog
32-1330-0034
Primary DI / UDI-DI
D78832133000341
FDA product code
EJF
GMDN term
Orthodontic bracket, metal
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket, metal

Other devices from GC Orthodontics America Inc.

See all devices from GC Orthodontics America Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No