NQA · Class III — High Risk (PMA approval required, life-sustaining) · Dental · 21 CFR 872.3930
Classification
FDA Product Code
NQA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 872.3930
Review panel
DE
Medical specialty
Dental
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.