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FDA 510(k)

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

K-Number: K222836 · 2023-05-15

ApplicantInstitut Straumann AG
Decision Date2023-05-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2023-05-15 under approval number K222836. 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® Variobase® Abutments and Straumann® n!ce® Zirconia discs?

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs is a medical device that received FDA 510(k) clearance on 2023-05-15. It is manufactured by Institut Straumann AG. The 510(k) number is K222836.

When was Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs approved by the FDA?

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs received FDA 510(k) clearance on 2023-05-15, under approval number K222836.

What company makes Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs?

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs?

The FDA product code for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs is NHA.

Related Clinical Trials

NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT06086873 Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA RECRUITING

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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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