510(k) K182081
K182081 is an FDA 510(k) premarket notification submitted by Jdentalcare Srl for the device "JDentalCare Implant System JDIcon". The FDA issued a decision of Substantially Equivalent on Jun 26, 2020. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Jdentalcare Srl has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2020
- Date Received
- Aug 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type