FDA product code NPZ

Bone Grafting Material, Dental, With Biologic Component

Dental·Class 3·21 CFR 872.3930·Implantable
US regulatory classifications
US Product Code (FDA)
NPZ
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 872.3930
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Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Bone Grafting Material, Dental, With Biologic Component is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.