FDA product code NQA: Biologic Material, Dental
NQA is the FDA product code for biologic material, dental. It is a Class III device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. Devices under NQA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 7 recalls for NQA devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Biologic Material, Dental |
| Device class | Class III |
| Regulation | 21 CFR 872.3930 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NQA devices
7 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-17.
| Year | Recalls |
|---|---|
| 2018 | 6 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NQA?
NQA is the FDA product code for biologic material, dental. It is a Class III device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is NQA?
Class III, regulation 21 CFR 872.3930. Typical premarket route: PMA.
Have NQA devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2025-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NQA
- Run a recall and safety report across every NQA manufacturer
- Watch product code NQA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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