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FDA 510(k)

MTA2.3 MATERIALS

K-Number: K181917 · 2019-01-11

ApplicantNuSmile, Ltd.
Decision Date2019-01-11
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MTA2.3 MATERIALS is a medical device manufactured by NuSmile, Ltd.. It received FDA 510(k) clearance on 2019-01-11 under approval 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. It is manufactured by NuSmile, Ltd.. The 510(k) number is K181917.

When was MTA2.3 MATERIALS approved by the FDA?

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

What company makes MTA2.3 MATERIALS?

MTA2.3 MATERIALS is manufactured by NuSmile, Ltd..

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

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

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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.

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