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FDA 510(k)

Straumann TLX Variobase C

K-Number: K220878 · 2022-06-16

Decision Date2022-06-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann TLX Variobase C is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2022-06-16 under approval number K220878. 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 TLX Variobase C?

Straumann TLX Variobase C is a medical device that received FDA 510(k) clearance on 2022-06-16. It is manufactured by Institut Straumann AG. The 510(k) number is K220878.

When was Straumann TLX Variobase C approved by the FDA?

Straumann TLX Variobase C received FDA 510(k) clearance on 2022-06-16, under approval number K220878.

What company makes Straumann TLX Variobase C?

Straumann TLX Variobase C is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann TLX Variobase C?

The FDA product code for Straumann TLX Variobase C 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.