510(k) K160382
K160382 is an FDA 510(k) premarket notification submitted by Rhein'83 Srl for the device "OT EQUATOR". The FDA issued a decision of Substantially Equivalent on Aug 11, 2016. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Rhein'83 Srl has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2016
- Date Received
- Feb 10, 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.