Kensey Nash Fibrillar Collagen Dental Membrane
FDA 510(k) K090919 · Kensey Nash Corp.
510(k) numberK090919
Submission
- Device name
- Kensey Nash Fibrillar Collagen Dental Membrane
- Applicant
- Kensey Nash Corp.
Exton, PA, US - Received
- April 1, 2009
- Decision date
- October 2, 2009
- 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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| K121310 | Mesothelium Dental MembraneNPL · Traditional | 07/11/2013SE |
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| K103787 | Medeor MatrixFTM · Traditional | 02/07/2011SE |
| K094061 | Kensey Nash Ecm Surgical PatchFTM · Traditional | 05/18/2010SE |
| K091192 | Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXNPL · Traditional | 11/02/2009SE |
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)FTM · Traditional | 10/22/2009SE |
| K073519 | Quickcat Extraction Catheter, Model 60090-01QEZ · Special | 03/28/2008SE |
| K073162 | Safe-Cross(R) Radio Frequency Total Occlusion Crossing System, Safe-Cross(R) Radio…DQX · Special | 02/08/2008SE |
| K071695 | Kensey Nash Macropore ShieldFTL · Traditional | 12/31/2007SE |
| K072384 | Modification to Copios Bone Void Filler Sponge & PasteMQV · Special | 09/21/2007SE |
Questions and answers
When was Kensey Nash Fibrillar Collagen Dental Membrane cleared by the FDA?
Kensey Nash Fibrillar Collagen Dental Membrane (K090919) received a 510(k) decision of Substantially Equivalent on October 2, 2009, 184 days after the submission was received.
What is the product code of K090919?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.