MTA2.1 Material Resin Root Canal Filling

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK140955	Date11 Jun 2014Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K140955

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K140955
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

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

MTA2 Root And Pulp Materials K122892 11 Dec 2012 FDA record · FDA summary

Cited by

MTA2.2 Material K161239 1 Sep 2016 FDA record · FDA summary

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

Overview

AI-generated summary, 24 Sep 2026

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

The MTA2.1 Material is a resin-based root canal filling material designed for use in dental procedures involving contact with vital pulp tissue and periradicular tissue. It is intended for applications such as pulp capping, cavity lining, base material, pulpotomy, and root-end filling, as well as sealing and obturation of root canals.

Supplied as a non-sterile, single-use material for dental clinical settings, the MTA2.1 Material is regulated under FDA 510(k) clearance (K140955) as a Class II device with product code KIF. It is not indicated for MRI safety assessment, and no sterility, storage, or reuse specifications are provided in the data.

Devices cleared under K140955

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K140955
		UDI-DI	Size and differences
NeoMTA Plus MN250 Avalon Biomed Inc.	MN250	08575700061252	Weight 2.5 g Prescription: yes	No longer on the market
NuSmile NeoMTA NMTA 7.0 NUSMILE, LTD	None / NMTA 7.0	00862487000320	Weight 7.0 g Prescription: yes	No longer on the market
NuSmile NeoMTA NMTA0.5 NUSMILE, LTD	None / NMTA0.5	00862487000306	Weight 0.5 g Prescription: no	No longer on the market
NuSmile NeoMTA NMTA1.0 NUSMILE, LTD	NMTA1.0	00862487000351	Weight 1.0 g Prescription: no	No longer on the market
NuSmile NeoMTA NMTA2.5 NUSMILE, LTD	None / NMTA2.5	00862487000313	Weight 2.5 g Prescription: yes	No longer on the market

Similar devices

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

Other devices from Avalon Biomed Inc.

MTA2 Root and Pulp Materials

Class II
MTA2.2 Material

Class II