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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 the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-07-11 under 510(k) 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. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251786.

When did Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® receive FDA 510(k) clearance?

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

Who is the listed applicant for Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®?

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

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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Related Devices (Code: NPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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