FDA product code NPM: Bone Grafting Material, Animal Source
NPM is the FDA product code for bone grafting material, animal source. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. FDA has cleared 40 510(k) submissions under NPM, 9 in the last five years, from 22 different applicants. The average 510(k) review took 226 days (median 206); 193 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 11 recalls for NPM devices, 1 initiated in the last five years.
Definition
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Classification
| Field | Value |
|---|---|
| Device name | Bone Grafting Material, Animal Source |
| Device class | Class II |
| Regulation | 21 CFR 872.3930 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NPM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 169 |
| 2018 | 2 | 312 |
| 2020 | 3 | 197 |
| 2021 | 2 | 167 |
| 2023 | 2 | 198 |
| 2024 | 3 | 291 |
| 2025 | 3 | 85 |
| 2026 | 1 | 204 |
Compare with all 510(k) review times · Search every NPM clearance
Top NPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Geistlich Pharma AG | 8 | 2025-07-11 |
| Collagen Matrix, Inc. | 7 | 2021-04-02 |
| Purgo Biologics, Inc. | 3 | 2024-07-24 |
| Medpark Co., Ltd. | 2 | 2026-06-16 |
| Sigmagraft, Inc. | 2 | 2023-03-18 |
17 more applicants have NPM clearances. See the full list in Caduvo.
Most recent NPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253723 | Medpark Co., Ltd. | BOSS | 2026-06-16 | 204 |
| K251786 | Geistlich Pharma AG | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | 2025-07-11 | 30 |
| K251613 | Geistlich Pharma AG | SwissGraft X | 2025-06-26 | 30 |
| K242510 | Geistlich Pharma AG | Geistlich Bio-Flow® | 2025-03-07 | 196 |
| K240133 | Collagen Solutions, LLC | Xenograft Bovine Bone Particulate | 2024-08-16 | 211 |
Recalls for NPM devices
11 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-02-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code NPM?
NPM is the FDA product code for bone grafting material, animal source. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is NPM?
Class II, regulation 21 CFR 872.3930. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPM?
Across 40 cleared submissions the average was 226 days from receipt to decision (median 206).
Which companies have the most NPM clearances?
Geistlich Pharma AG (8); Collagen Matrix, Inc. (7); Purgo Biologics, Inc. (3); Medpark Co., Ltd. (2); Sigmagraft, Inc. (2).
Have NPM devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2022-02-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NPM
- Run a recall and safety report across every NPM manufacturer
- Watch product code NPM 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