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510(k) K102015

OSTEON, OSTEON SINUS, OSTEON LIFTING by Genoss Co., Ltd. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2010
Date Received
July 16, 2010
Clearance Type
Special
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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