510(k) K091026
K091026 is an FDA 510(k) premarket notification submitted by Pou YU Biotechnology Co., Ltd. for the device "TDS ABUTMENT FOR NOBEL BIOCARE REPLACE". The FDA issued a decision of Substantially Equivalent on Jun 24, 2009. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Pou YU Biotechnology Co., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 2009
- Date Received
- Apr 10, 2009
- 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.