510(k) K251556

Device 300423 Granules by Geistlich Pharma AG — Product Code MQV

K251556 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Device 300423 Granules". The FDA issued a decision of Substantially Equivalent on July 17, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Geistlich Pharma AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
May 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type