NPL
- Product code
- NPL
- Device name
- Barrier, Animal Source, Intraoral
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3930
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 57 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242817 | 2025-12-12 | Botiss Biomaterials GmbH | Jason membrane | |
| K250512 | 2025-12-05 | Neo Modulus (Suzhou) Medical Sci-Tech … | Augmented Gingival Matrix | |
| K252253 | 2025-11-25 | Geistlich Pharma AG | Geistlich Mucograft® /Geistlich Mucograft® Seal; Ge… | |
| K251062 | 2025-08-14 | Geistlich Pharma AG | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geist… | |
| K250833 | 2025-04-15 | Geistlich Pharma AG | SwissMembrane X; SwissMembrane X Socket | |
| K233203 | 2024-05-01 | Collagen Matrix, Inc. | Soft Tissue Augmentation Resorbable Matrix | |
| K231513 | 2024-02-16 | Beijing Biosis Healing Biolog Ical Tec… | Oral Matrix | |
| K231305 | 2024-01-23 | Aroa Biosurgery , Ltd. | Endoform Dental Membrane | |
| K230091 | 2023-10-06 | Purgo Biologics, Inc. | THE Cover |
Official FDA classification page: NPL
Classification and pathway per current FDA publications. Data from openFDA (CC0).