510(k) K050641
K050641 is an FDA 510(k) premarket notification submitted by Nobel Biocare USA, LLC for the device "ZYGOMA TIUNITE". The FDA issued a decision of Substantially Equivalent on Apr 7, 2005. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Nobel Biocare USA, LLC has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2005
- Date Received
- Mar 14, 2005
- Clearance Type
- Special
- 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.