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Premium Line 111-1516-000

by EC Certification Service GmbH 3 variants

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

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 NumberD82911115160000051 UDI-DI Date1 Jul 2026ListedStatusListed 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  • Withdrawn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
Premium Line
Generic Name
Orthodontic bracket, plastic, single-use
Model / Reference
111-1516-000
Primary DI / UDI-DI
D82911115160000051
FDA Product Code
DYW
GMDN Term
Orthodontic bracket, plastic, single-use
Device Class
Class II
Regulation Number
872.5470
GUDID distribution status
In Commercial Distribution

Other devices from EC Certification Service GmbH

See all devices from EC Certification Service GmbH →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

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