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FDA 510(k)

Straumann® Retentive System – Novaloc TiN Abutments

K-Number: K193046 · 2020-08-13

ApplicantInstitut Straumann AG
Decision Date2020-08-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® Retentive System – Novaloc TiN Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2020-08-13 under approval number K193046. 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® Retentive System – Novaloc TiN Abutments?

Straumann® Retentive System – Novaloc TiN Abutments is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by Institut Straumann AG. The 510(k) number is K193046.

When was Straumann® Retentive System – Novaloc TiN Abutments approved by the FDA?

Straumann® Retentive System – Novaloc TiN Abutments received FDA 510(k) clearance on 2020-08-13, under approval number K193046.

What company makes Straumann® Retentive System – Novaloc TiN Abutments?

Straumann® Retentive System – Novaloc TiN Abutments is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann® Retentive System – Novaloc TiN Abutments?

The FDA product code for Straumann® Retentive System – Novaloc 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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