NPZ — Bone Grafting Material, Dental, With Biologic Component Class III
FDA product code NPZ covers "Bone Grafting Material, Dental, With Biologic Component", a Class III medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants.
Classification Details
- Product Code
- NPZ
- Device Class
- Class III
- Regulation Number
- 872.3930
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Definition
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material 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.