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K-Files N120 L31

by Micro Mega

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ015600297731 UDI-DI Date22 Dec 2020ListedStatusListed 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  • Withdrawn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
K-Files
Generic name
Manual endodontic file/rasp, reusable
Model / Ref / Catalog
N120 L31, 60029773
Primary DI / UDI-DI
J015600297731
FDA product code
EKS
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from Micro Mega

See all devices from Micro Mega →

Properties

  • Supplied sterile
  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No