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MTA2 Root and Pulp Materials

by Avalon Biomed Inc.

510(k) K122892

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 NumberK122892 Date11 Dec 2012ClearedStatusActive

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  • Withdrawn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
FDA applicant
Avalon Biomed, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3820
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 MTA2 Root and Pulp Materials is a Root Canal Filling Resin (FDA classification 872.3820) designed for dental procedures involving pulp and periradicular tissues. It serves as a biocompatible material for root canal obturation and sealing, promoting tissue compatibility and structural integrity in endodontic treatments. Its formulation supports sealing properties essential for preventing microbial leakage and maintaining long-term periradicular healing.

Supplied as a single-use dental material, MTA2 is intended for clinical use in controlled environments such as dental offices or clinics. The product is not sterile at time of shipment but is intended to be prepared and applied under aseptic conditions. No specific MRI safety information is provided, and its use adheres to standard dental infection control protocols. Authorized under FDA 510(k) clearance (K122892) as a Class II device, it complies with dental regulatory standards for root canal filling materials.

Similar devices

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

Other devices from Avalon Biomed Inc.