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Standardized Paper Points 604025

by MAILLEFER INSTRUMENTS HOLDING Sàrl

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 NumberJ0036040251 UDI-DI Date12 Sep 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  • Withdrawn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
Standardized Paper Points
Generic Name
Endodontic paper point
Model / Ref / Catalog
604025
Primary DI / UDI-DI
J0036040251
FDA Product Code
EKN
GMDN Term
Endodontic paper point
Device Class
Class I
Regulation Number
872.3830
GUDID distribution status
In Commercial Distribution

Other devices from MAILLEFER INSTRUMENTS HOLDING Sàrl

See all devices from MAILLEFER INSTRUMENTS HOLDING Sàrl →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

  • 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
  • Manufacturing Date: No