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MTA Root Canal Sealer

by Dentsply Interntional

510(k) K080203

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080203 Date26 Mar 2008ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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.

MTA Root Canal Sealer is a powder and liquid system for endodontic procedures. Mixing the powder and liquid creates a colloidal gel that solidifies to form an impermeable barrier, sealing pathways between the root canal system and external tooth surfaces.

It is used by dental professionals in a clinical setting to facilitate root canal obturation. The device is supplied as a powder and liquid system, requires mixing prior to use, and is classified as a Class II medical device under FDA 510(k) clearance K080203 with product code KIF and regulation number 872.3820.

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Questions

AI-generated answers, 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.

  • What is the MTA Root Canal Sealer used for?

    The MTA Root Canal Sealer is used by dental professionals in a clinical setting to facilitate root canal obturation by creating an impermeable barrier that seals pathways between the root canal system and external tooth surfaces after mixing the powder and liquid components.

  • How is the MTA Root Canal Sealer supplied and prepared for use?

    The device is supplied as a powder and liquid system that requires mixing prior to use; the powder and liquid are combined to create a colloidal gel that subsequently solidifies to form the sealing barrier during endodontic procedures.

  • Is the MTA Root Canal Sealer a single-use or reusable device?

    The MTA Root Canal Sealer is intended for single-use per patient procedure, as it is mixed fresh before each application and cannot be resterilized or reused after initial use due to its chemical setting mechanism.

  • What regulatory pathway was used for the MTA Root Canal Sealer?

    The MTA Root Canal Sealer received FDA 510(k) clearance under submission K080203, classified as a Class II medical device with product code KIF and regulation number 872.3820, based on a traditional substantial equivalence determination.