Jason membrane
FDA 510(k) K242817 · Botiss Biomaterials GmbH
510(k) numberK242817
Submission
- Device name
- Jason membrane
- Applicant
- Botiss Biomaterials GmbH
Zossen, DE - Received
- September 18, 2024
- Decision date
- December 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPL – Barrier, Animal Source, Intraoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
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.
Other 510(k)s with product code NPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250512 | Augmented Gingival MatrixNPL · Traditional | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 12/05/2025SE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional | Geistlich Pharma AG | 11/25/2025SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | Geistlich Pharma AG | 08/14/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | Geistlich Pharma AG | 04/15/2025SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | Collagen Matrix, Inc. | 05/01/2024SE |
| K231513 | Oral MatrixNPL · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 02/16/2024SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | Aroa Biosurgery , Ltd. | 01/23/2024SE |
| K230091 | THE CoverNPL · Traditional | Purgo Biologics, Inc. | 10/06/2023SE |
| K223912 | InterCollagen® GuideNPL · Traditional | Sigmagraft, Inc. | 08/17/2023SE |
| K213904 | Kerecis OralNPL · Traditional | Kerecis | 09/30/2022SE |
Questions and answers
When was Jason membrane cleared by the FDA?
Jason membrane (K242817) received a 510(k) decision of Substantially Equivalent on December 12, 2025, 450 days after the submission was received.
What is the product code of K242817?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.