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Integrated Endo System Meet Endo-II

by Denjoy Dental Co., Ltd 2 variants

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 Number06979865810007 UDI-DI Date31 Mar 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  • Withdrawn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
Integrated Endo System
Generic Name
Endodontic obturation system
Model / Reference
Meet Endo-II
Primary DI / UDI-DI
06979865810007
510(k) Number
FDA Product Code
EKR, LQY, EKX, ELC
GMDN Term
Endodontic obturation system
Device Class
Class I
Regulation Number
872.4565, 872.4200, 872.4850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Dry Heat Sterilization

Related devices

Cleared under the same submission (K242317)

Show all (11)

Other devices from Denjoy Dental Co., Ltd

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No