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Ovation S 410-212-80

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 NumberD807410212801 UDI-DI Date19 Jan 2018ListedStatusListed 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  • Withdrawn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
Ovation S
Generic Name
Orthodontic bracket, ceramic
Model / Ref / Catalog
410-212-80
Description
Ovation ® S EURO / 022 U1L (17T,4A)
Primary DI / UDI-DI
D807410212801
FDA Product Code
EJF
GMDN Term
Orthodontic bracket, ceramic
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
Not in Commercial Distribution

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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