Instrumentarium Dental, PaloDEx Group Oy
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1091-2014 | Class II | The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) | January 14, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133231 | DIGORA OPTIME | March 20, 2014 |
| K093683 | ORTHOPANTOMOGRAPH OP300 | October 6, 2010 |
| K092591 | ORTHOPANTOMOGRAPH OP30 | November 20, 2009 |
| K081925 | SNAPSHOT | September 2, 2008 |
| K063837 | SIGMA M | July 2, 2007 |