510(k) K161989
K161989 is an FDA 510(k) premarket notification submitted by Sweden & Martina S.P.A. for the device "PREMIUM Implant Systems SHELTA Implant Systems". The FDA issued a decision of Substantially Equivalent on Feb 1, 2018. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Sweden & Martina S.P.A. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2018
- Date Received
- Jul 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abutment, Implant, Dental, Endosseous
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
- 510(k)
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.