Biologic Material, Dental
The dental biologic material is a dental substance, used with or without other devices, that contains biologic or drug components such as growth-factor proteins intended to stimulate or inhibit tissue growth in the oral and maxillofacial region, distinct from simple bone grafting materials. It is classified as FDA Class 3 under regulation 872.3930 in the Dental specialty, requiring Premarket Approval (PMA). Product code NQA carries an implant flag and is not eligible for third-party review.
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Basic Information
- Product Code
- NQA
- Device Class
- FDA class 3
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 2
Device Characteristics
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.
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.