Sealex Extra Root Canal Sealer

by Baladent

510(k) K962885

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K962885↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK962885	Date30 Aug 1996Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K962885
FDA Product Code: KIF

Device Class: Class II
Regulation: 21 CFR Part 872.3820
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth. The device is classified as a Class II medical device under FDA regulation number 872.3820 and product code KIF.

It received FDA 510(k) clearance (K962885) on August 30, 1996, as substantially equivalent to a predicate device. The device is supplied by Baladent, located in Chicago, Illinois, and is intended for dental use in root canal obturation procedures.