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Experience 11-134D-Z010

by GC Orthodontics America Inc. 2 variants

Experience 11-134D-Z010 is a Class II device made by GC Orthodontics America Inc., listed in FDA GUDID since 1 Aug 2016 (UDI-DI E53511134DZ0101), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE53511134DZ0101 UDI-DI Date1 Aug 2016ListedStatusListed 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  • Withdrawn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
Experience
Generic name
Orthodontic bracket, ceramic
Model / Ref / Catalog
11-134D-Z010
Primary DI / UDI-DI
E53511134DZ0101
FDA product code
NJM
GMDN term
Orthodontic bracket, ceramic
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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Properties

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