Straumann Membragel
FDA 510(k) K082111 · Institut Straumann AG
510(k) numberK082111
Submission
- Device name
- Straumann Membragel
- Applicant
- Institut Straumann AG
Andover, MA, US - Received
- July 28, 2008
- Decision date
- May 22, 2009
- 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 |
| K210797 | Bio-MEM Ti Reinforced MembraneNPK · Traditional | B&Medi Co., Ltd. | 08/18/2022SE |
| 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 |
More from Sunstar Americas, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | 06/03/2026SE |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional | 05/07/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | 03/10/2026SE |
| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
Questions and answers
When was Straumann Membragel cleared by the FDA?
Straumann Membragel (K082111) received a 510(k) decision of Substantially Equivalent on May 22, 2009, 298 days after the submission was received.
What is the product code of K082111?
The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.