VANTAGE MODEL V5000, V5100, V5000C, V5100C
FDA 510(k) clearance K122643 · decided 2013-01-07
Clearance details
- K-number
- K122643
- Device name
- VANTAGE MODEL V5000, V5100, V5000C, V5100C
- Applicant
- Midmark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-29
- Decision date
- 2013-01-07
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lincolnshire, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Vantage Digital Panoramic System delivers high-value features standard on every system recall (Z-0651-2014) | Midmark Corp dba Progeny Inc | 2014-01-09 |