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JAS Fill Gutta-Percha Needles JAS GPN

by Denjoy Dental Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number06979865810113 UDI-DI Date24 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
JAS Fill Gutta-Percha Needles
Generic Name
Dental surgical power tool motorized handpiece/set, electric
Model / Reference
JAS GPN
Primary DI / UDI-DI
06979865810113
510(k) Number
FDA Product Code
EKX, ELC, EKR
GMDN Term
Dental surgical power tool motorized handpiece/set, electric
Device Class
Class I
Regulation Number
872.4200, 872.4850, 872.4565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K242317)

Show all (11)

Other devices from Denjoy Dental Co., Ltd

See all devices from Denjoy Dental Co., Ltd →

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No