FDA product code NPZ: Bone Grafting Material, Dental, With Biologic Component

NPZ is the FDA product code for bone grafting material, dental, with biologic component. It is a Class III device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. Devices under NPZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 1 recall for NPZ devices.

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.

Classification

Recalls for NPZ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-02-17.

Frequently asked questions

What is FDA product code NPZ?

NPZ is the FDA product code for bone grafting material, dental, with biologic component. It is a Class III device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.

What device class is NPZ?

Class III, regulation 21 CFR 872.3930. Typical premarket route: PMA.

Have NPZ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2005-02-17.

Next steps

• Run an FDA pathway report with predicate devices for product code NPZ
• Run a recall and safety report across every NPZ manufacturer
• Watch product code NPZ 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.

All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times