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SpiritMB 494-0300

by Ormco Corporation

SpiritMB 494-0300 is a Class II device made by Ormco Corporation, listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00889989007039), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00889989007039 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
SpiritMB
Generic name
Orthodontic bracket, plastic, single-use
Model / reference
494-0300
Primary DI / UDI-DI
00889989007039
FDA product code
DYW
GMDN term
Orthodontic bracket, plastic, single-use
Device class
Class II
Regulation number
872.5470
GUDID distribution status
Not in Commercial Distribution

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)