510(k) K191458
K191458 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "Legacy SMARTBase Abutments". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Implant Direct Sybron Manufacturing, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2019
- Date Received
- May 31, 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
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.