NPL — Barrier, Animal Source, Intraoral Class II
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 | December 12, 2025 |
| K250512 | neo modulus (suzhou) medical sci-tech co | Augmented Gingival Matrix | December 5, 2025 |
| K252253 | geistlich pharma | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | November 25, 2025 |
| K251062 | geistlich pharma | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; G | August 14, 2025 |
| K250833 | geistlich pharma | SwissMembrane X; SwissMembrane X Socket | April 15, 2025 |
| K233203 | collagen matrix | Soft Tissue Augmentation Resorbable Matrix | May 1, 2024 |
| K231513 | beijing biosis healing biolog ical technology co | Oral Matrix | February 16, 2024 |
| K231305 | aroa biosurgery | Endoform Dental Membrane | January 23, 2024 |
| K230091 | purgo biologics | THE Cover | October 6, 2023 |
| K223912 | sigmagraft | InterCollagen® Guide | August 17, 2023 |
| K213904 | kerecis | Kerecis Oral | September 30, 2022 |
| K212509 | datum dental | OSSIX Breeze | July 18, 2022 |
| K212463 | geistlich pharma | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Gei | April 5, 2022 |
| K210280 | geistlich pharma | Geistlich Mucograft®, Geistlich Mucograft® Seal | March 3, 2021 |
| K201241 | orthocell | Striate+ | January 11, 2021 |
| K192612 | kerecis limited | Kerecis Gingiva Graft | November 13, 2020 |
| K200623 | sk bioland co | OssGuide | October 2, 2020 |
| K192042 | geistlich pharma | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Gei | August 29, 2019 |
| K173562 | institut straumann | Straumann Jason Membrane | July 9, 2018 |
| K171050 | geistlich pharma | Geistlich Fibro-Gide | November 9, 2017 |