510(k) K200597
K200597 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC (On Behalf Of Institut Straumann Ag) for the device "Straumann BLX Gold Abutments". The FDA issued a decision of Substantially Equivalent on Aug 19, 2020. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Straumann USA, LLC (On Behalf Of Institut Straumann Ag) has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2020
- Date Received
- Mar 9, 2020
- 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.