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Elation® Mb 133-651-60

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 NumberD807133651601 UDI-DI Date26 Jun 2017ListedStatusListed 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  • Withdrawn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

Trade Name
Elation® Mb
Generic Name
Orthodontic bracket, plastic, single-use
Model / Ref / Catalog
133-651-60
Description
ELATION® MB Base Rx 018/L5 -22T
Primary DI / UDI-DI
D807133651601
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 Dentsply Sirona Orthodontics Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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