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FDA 510(k)

Straumann Ceramic Healing Abutments

K-Number: K192893 · 2020-01-03

Decision Date2020-01-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Ceramic Healing Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2020-01-03 under approval number K192893. 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 Straumann Ceramic Healing Abutments?

Straumann Ceramic Healing Abutments is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Institut Straumann AG. The 510(k) number is K192893.

When was Straumann Ceramic Healing Abutments approved by the FDA?

Straumann Ceramic Healing Abutments received FDA 510(k) clearance on 2020-01-03, under approval number K192893.

What company makes Straumann Ceramic Healing Abutments?

Straumann Ceramic Healing Abutments is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann Ceramic Healing Abutments?

The FDA product code for Straumann Ceramic Healing Abutments 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.