LYC · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3930
Classification
FDA Product Code
LYC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3930
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
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.