Product code EKA— Dental
FR ROOT CANAL SEALER
- Classification name
- File, Margin Finishing, Operative
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code EKA
FDA has cleared devices under product code EKA between 1982 and 1983, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1983
- 1982
Top applicants under product code EKA
Recent clearances under product code EKA
Data sourced from openFDA. This site is unofficial and independent of the FDA.