Ortek Therapeutics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170822 | Electronic Caries Detector | September 11, 2017 |
| K003482 | PROCLUDE-SENSITIVE | February 1, 2001 |
| K002989 | PROCLUDE | December 14, 2000 |