FDA product code NPL: Barrier, Animal Source, Intraoral
NPL is the FDA product code for barrier, animal source, intraoral. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. FDA has cleared 57 510(k) submissions under NPL, 13 in the last five years, from 32 different applicants. The average 510(k) review took 225 days (median 203); 227 days on average over the last three years. FDA has posted 11 recalls for NPL devices.
Definition
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Animal Source, Intraoral |
| 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 NPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 189 |
| 2018 | 1 | 234 |
| 2019 | 1 | 29 |
| 2020 | 2 | 314 |
| 2021 | 2 | 139 |
| 2022 | 3 | 292 |
| 2023 | 2 | 249 |
| 2024 | 3 | 249 |
| 2025 | 5 | 205 |
Compare with all 510(k) review times · Search every NPL clearance
Top NPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Collagen Matrix, Inc. | 10 | 2024-05-01 |
| Geistlich Pharma AG | 9 | 2025-11-25 |
| Ed. Geistlich Soehne AG Fuer Chemische Industrie | 5 | 2008-05-30 |
| Datum Dental, Ltd. | 3 | 2022-07-18 |
| Kensey Nash Corp. | 2 | 2009-11-02 |
27 more applicants have NPL clearances. See the full list in Caduvo.
Most recent NPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242817 | Botiss Biomaterials GmbH | Jason membrane | 2025-12-12 | 450 |
| K250512 | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | Augmented Gingival Matrix | 2025-12-05 | 287 |
| K252253 | Geistlich Pharma AG | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | 2025-11-25 | 127 |
| K251062 | Geistlich Pharma AG | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | 2025-08-14 | 132 |
| K250833 | Geistlich Pharma AG | SwissMembrane X; SwissMembrane X Socket | 2025-04-15 | 27 |
Recalls for NPL devices
11 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-05.
| Year | Recalls |
|---|---|
| 2019 | 7 |
Frequently asked questions
What is FDA product code NPL?
NPL is the FDA product code for barrier, animal source, intraoral. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is NPL?
Class II, regulation 21 CFR 872.3930. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPL?
Across 57 cleared submissions the average was 225 days from receipt to decision (median 203).
Which companies have the most NPL clearances?
Collagen Matrix, Inc. (10); Geistlich Pharma AG (9); Ed. Geistlich Soehne AG Fuer Chemische Industrie (5); Datum Dental, Ltd. (3); Kensey Nash Corp. (2).
Have NPL devices been recalled?
Yes: 11 product recalls across 4 recall events; the most recent began 2019-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NPL
- Run a recall and safety report across every NPL manufacturer
- Watch product code NPL 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.
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