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FDA 510(k)

Straumann TLX Variobase C

K-Number: K220878 · 2022-06-16

ApplicantInstitut Straumann AG
Decision Date2022-06-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann TLX Variobase C is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2022-06-16 under 510(k) 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. The listed applicant is Institut Straumann AG. The 510(k) number is K220878.

When did Straumann TLX Variobase C receive FDA 510(k) clearance?

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

Who is the listed applicant for Straumann TLX Variobase C?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

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

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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