FDA 510(k)

Straumann BoneCeramic

K-Number: K201051 · 2020-09-24

Decision Date2020-09-24

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Straumann BoneCeramic is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2020-09-24 under approval number K201051. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann BoneCeramic?

Straumann BoneCeramic is a medical device that received FDA 510(k) clearance on 2020-09-24. It is manufactured by Institut Straumann AG. The 510(k) number is K201051.

When was Straumann BoneCeramic approved by the FDA?

Straumann BoneCeramic received FDA 510(k) clearance on 2020-09-24, under approval number K201051.

What company makes Straumann BoneCeramic?

Straumann BoneCeramic is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann BoneCeramic?

The FDA product code for Straumann BoneCeramic is LYC.

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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.