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FDA 510(k)

MIS Ti-base abutment

K-Number: K211225 · 2021-07-28

Decision Date2021-07-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS Ti-base abutment is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2021-07-28 under approval number K211225. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIS Ti-base abutment?

MIS Ti-base abutment is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Dentsply Sirona. The 510(k) number is K211225.

When was MIS Ti-base abutment approved by the FDA?

MIS Ti-base abutment received FDA 510(k) clearance on 2021-07-28, under approval number K211225.

What company makes MIS Ti-base abutment?

MIS Ti-base abutment is manufactured by Dentsply Sirona.

What is the FDA product code for MIS Ti-base abutment?

The FDA product code for MIS Ti-base abutment is NHA.

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Official Source

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