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N/A 37-112-42

by Dentsply Sirona Orthodontics Inc.

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

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 NumberD80737112421 UDI-DI Date30 Sep 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthodontic bracket, metal
Model / Ref / Catalog
37-112-42
Primary DI / UDI-DI
D80737112421
FDA Product Code
EJF
GMDN Term
Orthodontic bracket, metal
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
Not in Commercial Distribution

Other devices from Dentsply Sirona Orthodontics Inc.

See all devices from Dentsply Sirona Orthodontics Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No