Barrier, Animal Source, Intraoral

NPL · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3930

Classification

FDA Product Code: NPL
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

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

Market data

Cleared 510(k) submissions: 57
Registered establishments: 57

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown