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FDA 510(k)

Elos Accurate Customized Abutment

K-Number: K222044 · 2022-11-30

Decision Date2022-11-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Elos Accurate Customized Abutment is a medical device manufactured by Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2022-11-30 under approval number K222044. 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 Elos Accurate Customized Abutment?

Elos Accurate Customized Abutment is a medical device that received FDA 510(k) clearance on 2022-11-30. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K222044.

When was Elos Accurate Customized Abutment approved by the FDA?

Elos Accurate Customized Abutment received FDA 510(k) clearance on 2022-11-30, under approval number K222044.

What company makes Elos Accurate Customized Abutment?

Elos Accurate Customized Abutment is manufactured by Elos Medtech Pinol A/S.

What is the FDA product code for Elos Accurate Customized Abutment?

The FDA product code for Elos Accurate Customized Abutment is NHA.

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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.