NPK · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3930
Classification
FDA Product Code
NPK
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 dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.