NPLClass II
Barrier, Animal Source, Intraoral
21 CFR 872.3930 / Dental
NPL is the FDA product code for Barrier, Animal Source, Intraoral, a class II device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "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". As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and 11 recalls.
Classification record
- Product code
- NPL
- Device name
- Barrier, Animal Source, Intraoral
- FDA 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.
- Regulation
- 21 CFR 872.3930
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 57
- Ingested recalls
- 11
Clearances, product code NPL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 4 |
| 2013 | 2 |
| 2014 | 5 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 5 |
Applicants with the most clearances
Product code NPL| Applicant | Clearances |
|---|---|
| Collagen Matrix, Inc | 10 |
| Geistlich Pharma AG | 9 |
| Ed. Geistlich Soehne AG Fuer Chemische Industrie | 5 |
| Datum Dental, Ltd. | 3 |
| DSM Biomedical, Inc. | 3 |
| Cook Biotech, Inc. | 2 |
| Kerecis Limited | 2 |
| AROA Biosurgery Inc. | 1 |
| Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 1 |
| Biom'Up SAS | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Armm, Inc.
- AROA Biosurgery Inc.
- Bausch & Lomb Incorporated
- Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)
- BBF Sterilisationsservice GmbH
- Beijing Biosis Healing Biological Technology Co., Ltd
- Biotrics Bioimplants AG
- Botiss Biomaterials GmbH
- Collagen Matrix, Inc
- Cook Biotech, Inc.
- Cook Incorporated
- Dental Implant Technologies, Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.