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FDA 510(k)

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

K-Number: K251786 · 2025-07-11

ApplicantGeistlich Pharma AG
Decision Date2025-07-11
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-07-11 under approval number K251786. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®?

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Geistlich Pharma AG. The 510(k) number is K251786.

When was Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® approved by the FDA?

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® received FDA 510(k) clearance on 2025-07-11, under approval number K251786.

What company makes Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®?

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® is manufactured by Geistlich Pharma AG.

What is the FDA product code for Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®?

The FDA product code for Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® is NPM.

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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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