STRAUMANN MEMBRAGEL
FDA 510(k) clearance K101956 · decided 2010-12-16
Clearance details
- K-number
- K101956
- Device name
- STRAUMANN MEMBRAGEL
- Applicant
- Straumann USA (On Behalf of Institut Straumann Ag)
- Decision
- Substantially Equivalent
- Date received
- 2010-07-12
- Decision date
- 2010-12-16
- Days to decision
- 157 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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| Neoss Ti Reinforced Membrane (K143327) | Neoss, Ltd. | 2015-04-13 |
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Recalls involving this device
No recalls on record reference this clearance.