510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NPZClass III

Bone Grafting Material, Dental, With Biologic Component

21 CFR 872.3930 / Dental
FDA source (opens on fda.gov)

NPZ is the FDA product code for Bone Grafting Material, Dental, With Biologic Component, a class III device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
NPZ
Device name
Bone Grafting Material, Dental, With Biologic Component
FDA 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.
Regulation
21 CFR 872.3930
Device class
Class III
Review panel
Dental
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code