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Bone Grafting Material, Synthetic

FDA product code LYC · 230 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3930
Review panel
DE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1979-10-09 – 2026-07-06

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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