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Keles Keyless Expander KKE1-10NL

by Aegis Star Dental Technologies 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 Number00860013171735 UDI-DI Date9 Dec 2024ListedStatusListed 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  • Withdrawn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
Keles Keyless Expander
Generic Name
Orthodontic palate expander screw, self-removable
Model / Reference
KKE1-10NL
Primary DI / UDI-DI
00860013171735
FDA Product Code
DYJ
GMDN Term
Orthodontic palate expander screw, self-removable
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No