CS 8100 CS 8100 ACCESS
FDA 510(k) clearance K120975 · decided 2012-06-22
Clearance details
- K-number
- K120975
- Device name
- CS 8100 CS 8100 ACCESS
- Applicant
- Trophy
- Decision
- Substantially Equivalent
- Date received
- 2012-04-02
- Decision date
- 2012-06-22
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Marne La Vallee Cedex 2, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or recall (Z-1377-2015) | Carestream Health, Inc. | 2015-04-03 |