SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
FDA 510(k) clearance K103136 · decided 2011-03-18
Clearance details
- K-number
- K103136
- Device name
- SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
- Applicant
- Materialise NV
- Decision
- Substantially Equivalent
- Date received
- 2010-10-25
- Decision date
- 2011-03-18
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the markin recall (Z-2287-2023) | Materialise N.V. | 2023-08-03 |