510(k) K242064
K242064 is an FDA 510(k) premarket notification submitted by Smart Denture Conversions, LLC for the device "Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Smart Denture Conversions, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2025
- Date Received
- July 15, 2024
- Clearance Type
- Abbreviated
- 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.