STRAUMANN MEMBRAGEL
FDA 510(k) clearance K082111 · decided 2009-05-22
Clearance details
- K-number
- K082111
- Device name
- STRAUMANN MEMBRAGEL
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2008-07-28
- Decision date
- 2009-05-22
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- NPK
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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| RPM Reinforced PTFE Mesh (K171774) | Osteogenics Biomedical, Inc. | 2017-10-19 |
| Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493) | Salvin Dental Specialties | 2016-09-08 |
| Cytoflex Tefguard Ti-Enforced Membrane (K151344) | Unicare Biomedical, Inc. | 2015-11-19 |
| Neoss Ti Reinforced Membrane (K143327) | Neoss, Ltd. | 2015-04-13 |
| GUIDOR BIORESORBABLE MATRIX BARRIER (K132325) | Sunstar Americas, Inc. | 2013-10-29 |
| MEDPOR CONTAIN CAN IMPLANT (K102184) | Porex Surgical, Inc. | 2011-01-07 |
| STRAUMANN MEMBRAGEL (K101956) | Straumann USA (On Behalf of Institut Straumann Ag) | 2010-12-16 |
Recalls involving this device
No recalls on record reference this clearance.