Product code ELE— Dental
HOLLOW BASKET TITANIUM DENTAL IMPLANT
- Classification name
- Implant, Subperiosteal
- Device class
- Class 2
- Regulation
- 21 CFR 872.3645
- Advisory panel
- Dental
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code ELE
FDA has cleared devices under product code ELE between 1980 and 2022, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 1986
- 1984
- 1980
Top applicants under product code ELE
Recent clearances under product code ELE
Data sourced from openFDA. This site is unofficial and independent of the FDA.