Product code ELN— Dental
IMPRESSION MATERIAL, ALGINATE
- Classification name
- Teeth, Preformed Gold Denture
- Device class
- Class 1
- Regulation
- 21 CFR 872.3580
- Advisory panel
- Dental
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ELN
FDA has cleared device under product code ELN, all in 1977, 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 ELN
Recent clearances under product code ELN
Data sourced from openFDA. This site is unofficial and independent of the FDA.