# Bone Grafting Material, Dental, With Biologic Component
> **Product code: NPZ** · Class III — High Risk (PMA approval required, life-sustaining) · Dental · 21 CFR 872.3930
## Classification
- **FDA Product Code:** NPZ
- **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

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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NPZ)
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