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510(k) K201546

OsOpia Synthetic Bone Void Filler by Revisios BV — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2020
Date Received
June 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

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