510(k) K071919
K071919 is an FDA 510(k) premarket notification submitted by Straumann USA (On Behalf of Institut Straumann Ag) for the device "P.004 ABUTMENTS". The FDA issued a decision of Substantially Equivalent on September 26, 2007. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Straumann USA (On Behalf of Institut Straumann Ag) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2007
- Date Received
- July 12, 2007
- 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.