Device 104 Particulate
K-Number: K251323 · 2026-01-22
ApplicantGeistlich Pharma AG
Decision Date2026-01-22
Product CodeKGN
DecisionSubstantially Equivalent
Device Summary
Device 104 Particulate is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2026-01-22 under approval number K251323. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Device 104 Particulate?
Device 104 Particulate is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Geistlich Pharma AG. The 510(k) number is K251323.
When was Device 104 Particulate approved by the FDA?
Device 104 Particulate received FDA 510(k) clearance on 2026-01-22, under approval number K251323.
What company makes Device 104 Particulate?
Device 104 Particulate is manufactured by Geistlich Pharma AG.
What is the FDA product code for Device 104 Particulate?
The FDA product code for Device 104 Particulate is KGN.
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K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
K190754Orthoss(R)
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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.