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510(k) K211551

Wishbone HA by Wishbone SA — Product Code NPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
May 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

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