510(k) K133421
K133421 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC for the device "STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW". The FDA issued a decision of Substantially Equivalent on April 17, 2014. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Straumann USA, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2014
- Date Received
- November 8, 2013
- 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.