Product code EKK— Dental
ENDODONTIC ELECTRONIC SPREADER HEATER
- Classification name
- Spreader, Pulp Canal Filling Material, Endodontic
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code EKK
FDA has cleared device under product code EKK, all in 1985, filed by 1 applicant company. 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.
Top applicants under product code EKK
Recent clearances under product code EKK
Data sourced from openFDA. This site is unofficial and independent of the FDA.