510(k) K153098
K153098 is an FDA 510(k) premarket notification submitted by SOADCO, S.L. for the device "KLOCKNER VEGA DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. SOADCO, S.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2016
- Date Received
- October 26, 2015
- Clearance Type
- Abbreviated
- 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