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Isrie

by Hansfive (Hangzhou) Dental Technology 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 Number06975043365987 UDI-DI Date7 Jan 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  • Withdrawn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

Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Reference
G3-G1708-19, G3-G1902-25, G3-G1506-25, G3-G2504-25, G3-G2506-25, G3-G3504-25
Description
Nickel Titanium Root Canal File 6 psc/pack Including G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25.
Primary DI / UDI-DI
06975043365987
FDA Product Code
EKS
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Dry Heat Sterilization

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No