DSM Biomedical Porcine Pericardium Dental Membrane
FDA 510(k) K160474 · Kensey Nash Corporation Dba Dsm Biomedical
510(k) numberK160474
Submission
- Device name
- DSM Biomedical Porcine Pericardium Dental Membrane
- Applicant
- Kensey Nash Corporation Dba Dsm Biomedical
Exton, PA, US - Received
- February 19, 2016
- Decision date
- June 7, 2016
- 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.
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| K230091 | THE CoverNPL · Traditional | Purgo Biologics, Inc. | 10/06/2023SE |
| K223912 | InterCollagen® GuideNPL · Traditional | Sigmagraft, Inc. | 08/17/2023SE |
More from Sigmagraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173572 | DSM Biomedical Calcium Phosphate Cement with MicrospheresMQV · Traditional | 05/09/2018SE |
| K173362 | DSM Biomedical Calcium Phosphate CementMQV · Traditional | 04/03/2018SE |
| K170245 | DSM Biomedical Dental Bone GraftNPM · Traditional | 05/16/2017SE |
| K141738 | Medeor Matrix Wound DressingKGN · Traditional | 02/17/2015SE |
| K133169 | Meso Tendon MatrixOWY · Traditional | 12/20/2013SE |
| K132025 | Meso Bilayer Surgical MeshFTM · Traditional | 10/30/2013SE |
Questions and answers
When was DSM Biomedical Porcine Pericardium Dental Membrane cleared by the FDA?
DSM Biomedical Porcine Pericardium Dental Membrane (K160474) received a 510(k) decision of Substantially Equivalent on June 7, 2016, 109 days after the submission was received.
What is the product code of K160474?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.