FDA product code · Dental
Biologic Material, Dental
1 FDA decision since 1996. 1 recall names this code; it is not Class I.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NQA 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 · NQA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQA
Too few NQA 510(k)s in any year since 2007 to give a median.
Recalls per year · NQA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQA
2in 2015
MAUDE reports naming product code NQA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 4 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 4 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 4 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in NQA? 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.