FDA 510(k)

MTA2.3 MATERIALS

K-Number: K181917 · 2019-01-11

Decision Date2019-01-11

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MTA2.3 MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is NuSmile, Ltd.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K181917. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTA2.3 MATERIALS?

MTA2.3 MATERIALS is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is NuSmile, Ltd.. The 510(k) number is K181917.

When did MTA2.3 MATERIALS receive FDA 510(k) clearance?

MTA2.3 MATERIALS received FDA 510(k) clearance on 2019-01-11, under 510(k) number K181917.

Who is the listed applicant for MTA2.3 MATERIALS?

The FDA 510(k) record lists NuSmile, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTA2.3 MATERIALS?

The FDA product code for MTA2.3 MATERIALS is KIF.

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.