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Bright MTA Sealer Plus

by GENOSS CO., Ltd.

510(k) K231480

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

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231480 Date28 Jul 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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, 1 Oct 2026

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

The Bright MTA Sealer Plus is a Resin, Root Canal Filling device, classified as a Class II medical product under FDA regulation 872.3820. This calcium silicate-based paste is designed for root canal therapy, providing a biocompatible and sealant material to fill and obturate the root canal system during endodontic procedures. Its formulation aims to promote apical closure and reduce the risk of periapical pathology by ensuring a tight seal within the canal space.

Supplied as a ready-to-use, injectable paste, the Bright MTA Sealer Plus is intended for single-use in dental settings. The device is non-sterile as shipped but must be sterilized prior to use, adhering to standard dental aseptic protocols. It is regulated under the FDA’s 510(k) pathway (K231480) and classified under the KIF product code, with a decision of Substantially Equivalent (SESE) to a predicate device. Compliance with dental sterilization and handling guidelines is essential to ensure safety and efficacy during root canal procedures.

Similar devices

Other devices filed under FDA product code KIF (Resin, Root Canal Filling).

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