← Back to catalogue

Endosolv E Resin Root Canal Filling

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K980633

by Specialites Septodont

Identifiers

510(k) Number
K980633 FDA 510(k)
FDA Product Code
KIF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3820 FDA 510(k)
Regulation Number
872.3820 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Endosolv E is a resin-based material classified as a root canal filling device. It is designed to seal and fill the root canal system during endodontic treatment, providing a durable and biocompatible restoration to prevent bacterial leakage and promote healing of the periapical tissues.

This device is supplied as a single-use, non-sterile material that requires mixing and application by a dental professional. It is intended for use in dental offices and clinics, adhering to standard endodontic protocols. The Endosolv E is regulated under the FDA’s 510(k) clearance and the Medical Device Directive (MDD), with a classification as a Class II device. Storage should follow manufacturer guidelines to maintain product integrity.

Frequently asked questions

Is the Endosolv E sterile when supplied, and if not, what preparation is required before use?

The Endosolv E is supplied as a non-sterile resin-based material. Since it is intended for direct application in root canal treatment, it must be mixed and prepared by a dental professional under aseptic conditions following standard endodontic protocols to ensure sterility at the point of use.

How is the Endosolv E intended to be used in clinical practice, and what type of setting is it designed for?

The Endosolv E is designed for single-use in dental offices and clinics during endodontic treatment. It is a root canal filling device that requires mixing by a dental professional before application to seal and fill the root canal system, preventing bacterial leakage and promoting periapical tissue healing. It adheres to standard endodontic protocols.

What regulatory pathways has the Endosolv E followed, and what classification does it hold under FDA and EU regulations?

The Endosolv E has obtained FDA 510(k) clearance and complies with the Medical Device Directive (MDD) in the EU. It is classified as a Class II device under both regulatory frameworks, indicating it carries a moderate risk level requiring specific controls to ensure safety and performance.

Are there different sizes or models of the Endosolv E, and if so, how are they distinguished?

The provided data does not specify distinct sizes or models of the Endosolv E beyond its classification as a resin-based root canal filling material. However, the product code (KIF) and registration numbers suggest it may be available in various packaging configurations or lot sizes, though these details are not explicitly detailed in the description.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Specialites Septodont

Sources (2)

  • FDA 510(k) K980633 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026