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02X KLO Metal Self-Ligating +5.2 BR02X-V

by Zhejiang Headway Medical Equipment Co., Ltd

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 Number06970469418514 UDI-DI Date26 Nov 2025ListedStatusListed 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  • Withdrawn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
02X KLO Metal Self-Ligating +5.2
Generic Name
Orthodontic bracket, metal
Model / Reference
BR02X-V
Primary DI / UDI-DI
06970469418514
FDA Product Code
EJF
GMDN Term
Orthodontic bracket, metal
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
In Commercial Distribution
Sterilization Method
Sound Waves

Other devices from Zhejiang Headway Medical Equipment Co., Ltd

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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