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510(k) K213260

CMFlexTM by Dimension Inx Corp. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2022
Date Received
September 30, 2021
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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