NPL — Barrier, Animal Source, Intraoral Class II
FDA product code NPL covers "Barrier, Animal Source, Intraoral", a Class II medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NPL
- Device Class
- Class II
- Regulation Number
- 872.3930
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242817 | Botiss Biomaterials | Jason membrane | Dec 12, 2025 |
| K250512 | Neo Modulus (Suzhou) Medical Sci-Tech Co | Augmented Gingival Matrix | Dec 5, 2025 |
| K252253 | Geistlich Pharma | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Nov 25, 2025 |
| K251062 | Geistlich Pharma | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; G | Aug 14, 2025 |
| K250833 | Geistlich Pharma | SwissMembrane X; SwissMembrane X Socket | Apr 15, 2025 |
| K233203 | Collagen Matrix | Soft Tissue Augmentation Resorbable Matrix | May 1, 2024 |
| K231513 | Beijing Biosis Healing Biolog Ical Technology Co | Oral Matrix | Feb 16, 2024 |
| K231305 | Aroa Biosurgery | Endoform Dental Membrane | Jan 23, 2024 |
| K230091 | Purgo Biologics | THE Cover | Oct 6, 2023 |
| K223912 | Sigmagraft | InterCollagen® Guide | Aug 17, 2023 |
| K213904 | Kerecis | Kerecis Oral | Sep 30, 2022 |
| K212509 | Datum Dental | OSSIX Breeze | Jul 18, 2022 |
| K212463 | Geistlich Pharma | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Gei | Apr 5, 2022 |
| K210280 | Geistlich Pharma | Geistlich Mucograft®, Geistlich Mucograft® Seal | Mar 3, 2021 |
| K201241 | Orthocell | Striate+ | Jan 11, 2021 |
| K192612 | Kerecis Limited | Kerecis Gingiva Graft | Nov 13, 2020 |
| K200623 | Sk Bioland Co | OssGuide | Oct 2, 2020 |
| K192042 | Geistlich Pharma | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Gei | Aug 29, 2019 |
| K173562 | Institut Straumann | Straumann Jason Membrane | Jul 9, 2018 |
| K171050 | Geistlich Pharma | Geistlich Fibro-Gide | Nov 9, 2017 |