510(k) K191152
K191152 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "MIS Ti-base Abutment". The FDA issued a decision of Substantially Equivalent on Jul 6, 2020. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 6, 2020
- Date Received
- May 1, 2019
- 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.