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Eclipse Passive 463-332

by Ortho Arch Company

Eclipse Passive 463-332 is a self-ligating orthodontic bracket (FDA Class I; FDA product code EJF, Bracket, Metal, Orthodontic) made by Ortho Arch Company, listed in FDA GUDID since 21 Jun 2023 (UDI-DI D90946333218), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD90946333218 UDI-DI Date21 Jun 2023ListedStatusListed 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  • Withdrawn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
Eclipse Passive
Generic name
Self-ligating orthodontic bracket
Model / Ref / Catalog
463-332
Primary DI / UDI-DI
D90946333218
FDA product code
EJF
GMDN term
Self-ligating orthodontic bracket
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

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Properties

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