Hydron Root Canal Filling System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K771921 ↗

FDA Product Code

KIF

Device Class

Class II

Regulation

21 CFR Part 872.3820

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Root Canal Filling Applicator Needles

  Class I

  FDA 510(k) K801484 Active Cleared 21 Jul 1980

• Hydron Burn Dressing Field Kit

  Class I

  FDA 510(k) K791865 Active Cleared 16 Nov 1979

• Mark IV Syringe

  Class I

  FDA 510(k) K801483 Active Cleared 21 Jul 1980

• Zeon Composite Resin Light Cure Sys

  Class II

  FDA 510(k) K820028 Active Cleared 11 Mar 1982

• I.V. Administration Set with Mini-Spike Open recall

  Class II

  FDA 510(k) K780551 Active Cleared 19 Apr 1978

• Zeon Composite Resin System

  Class II

  FDA 510(k) K820006 Active Cleared 22 Jan 1982

See all devices from National Patent Development Corp. →

• What is the Hydron Root Canal Filling System used for?

  The Hydron Root Canal Filling System is specifically designed for the obturation (filling) of root canals during endodontic treatment. It uses a resin-based material to seal the canal space effectively, preventing reinfection and leakage. This ensures long-term protection and stability for the treated tooth.

• Is the Hydron Root Canal Filling System sterile when packaged?

  No, the Hydron Root Canal Filling System is not sterile upon packaging. It is intended to be sterilized prior to use following standard dental sterilization protocols. This ensures safety and efficacy when used in clinical settings.

• How is the Hydron Root Canal Filling System supplied?

  The system is supplied as a single-use device, meaning each package is intended for one-time use only. This design minimizes cross-contamination risks and ensures consistent performance for each procedure.

• Can the Hydron Root Canal Filling System be reused?

  No, the Hydron Root Canal Filling System is explicitly designed for single-use only. Reusing it could compromise sterility and the integrity of the sealing material, potentially leading to complications during treatment.

• What regulatory approval does the Hydron Root Canal Filling System hold?

  The Hydron Root Canal Filling System received FDA 510(k) clearance under the Traditional 510(k) Review process, with a decision of Substantially Equivalent (SESE) in 1977. This clearance confirms its compliance with FDA regulations for root canal filling devices.