FDA product code · Dental
Bone Grafting Material, Dental, With Biologic Component
3 FDA decisions since 1999. 1 recall names this code; it is not Class I.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NPZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NPZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPZ
Too few NPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NPZ
No recall names NPZ since 2007.
Adverse event reports per year · NPZ
17in 2023
MAUDE reports naming product code NPZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 40 |
| 2008 | 10 | — | 0 | 24 |
| 2009 | 5 | — | 0 | 3 |
| 2010 | 4 | — | 0 | 22 |
| 2011 | 4 | — | 0 | 1 |
| 2012 | 6 | — | 0 | 4 |
| 2013 | 6 | — | 0 | 3 |
| 2014 | 3 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 4 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 7 | — | 0 | 0 |
| 2020 | 5 | — | 0 | 0 |
| 2021 | 5 | — | 0 | 0 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 5 | — | 0 | 17 |
| 2024 | 5 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 5 | — | 0 | — |
Planning a device in NPZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 872.3930.