Product code ELK— Dental
SR-ISOCETTE
- Classification name
- Teeth, Artificial, Backing And Facing
- Device class
- Class 1
- Regulation
- 21 CFR 872.3910
- Advisory panel
- Dental
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code ELK
FDA has cleared devices under product code ELK between 1976 and 1981, 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
- 1981
- 1976
Top applicants under product code ELK
Recent clearances under product code ELK
Data sourced from openFDA. This site is unofficial and independent of the FDA.