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FDA 510(k)

Straumann CARES Golden Ti/TiN Abutments

K-Number: K162848 · 2017-09-22

ApplicantInstitut Straumann AG
Decision Date2017-09-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CARES Golden Ti/TiN Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2017-09-22 under approval number K162848. 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 CARES Golden Ti/TiN Abutments?

Straumann CARES Golden Ti/TiN Abutments is a medical device that received FDA 510(k) clearance on 2017-09-22. It is manufactured by Institut Straumann AG. The 510(k) number is K162848.

When was Straumann CARES Golden Ti/TiN Abutments approved by the FDA?

Straumann CARES Golden Ti/TiN Abutments received FDA 510(k) clearance on 2017-09-22, under approval number K162848.

What company makes Straumann CARES Golden Ti/TiN Abutments?

Straumann CARES Golden Ti/TiN Abutments is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann CARES Golden Ti/TiN Abutments?

The FDA product code for Straumann CARES Golden Ti/TiN Abutments 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.

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