Bio-MEM Ti Reinforced Membrane
FDA 510(k) K210797 · B&Medi Co., Ltd.
510(k) numberK210797
Submission
- Device name
- Bio-MEM Ti Reinforced Membrane
- Applicant
- B&Medi Co., Ltd.
Incheon, KR - Received
- March 16, 2021
- Decision date
- August 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPK – Barrier, Synthetic, Intraoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
Other 510(k)s with product code NPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221851 | Lumina-PTFE TitaniumNPK · Traditional | Criteria Industria E Comercio DE Produtos… | 12/08/2023SE |
| K222549 | OpenTexNPK · Traditional | Purgo Biologics, Inc. | 05/11/2023SE |
| K211554 | InnoGenic Non-resorbable MembraneNPK · Traditional | Cowellmedi Co., Ltd. | 02/24/2023SE |
| K201187 | Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional | Osteogenics Biomedical, Inc. | 01/23/2021SE |
| K171774 | RPM Reinforced PTFE MeshNPK · Traditional | Osteogenics Biomedical, Inc. | 10/19/2017SE |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…NPK · Traditional | Salvin Dental Specialties | 09/08/2016SE |
| K151344 | Cytoflex Tefguard Ti-Enforced MembraneNPK · Traditional | Unicare Biomedical, Inc. | 11/19/2015SE |
| K143327 | Neoss Ti Reinforced MembraneNPK · Traditional | Neoss, Ltd. | 04/13/2015SE |
| K132325 | Guidor Bioresorbable Matrix BarrierNPK · Abbreviated | Sunstar Americas, Inc. | 10/29/2013SE |
| K102184 | Medpor Contain Can ImplantNPK · Traditional | Porex Surgical, Inc. | 01/07/2011SE |
Questions and answers
When was Bio-MEM Ti Reinforced Membrane cleared by the FDA?
Bio-MEM Ti Reinforced Membrane (K210797) received a 510(k) decision of Substantially Equivalent on August 18, 2022, 520 days after the submission was received.
What is the product code of K210797?
The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.