Bone Grafting Material, Dental, With Biologic Component
The dental bone grafting material with biologic component is a combination product consisting of a bone grafting material that incorporates biologic or drug components such as growth-factor proteins, intended to stimulate or inhibit tissue growth in the oral and maxillofacial region. It is classified as FDA Class 3 under regulation 872.3930 in the Dental specialty, requiring Premarket Approval (PMA) due to the inclusion of biologic components that pose greater risk than standard bone graft materials. Product code NPZ carries an implant flag and is not eligible for third-party review.
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Basic Information
- Product Code
- NPZ
- Device Class
- FDA class 3
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.