510(k) K092248
K092248 is an FDA 510(k) premarket notification submitted by Thommen Medical AG for the device "SPI CUSTOMIZABLE GINGIVA FORMER". The FDA issued a decision of Substantially Equivalent on September 25, 2009. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Thommen Medical AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2009
- Date Received
- July 28, 2009
- 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
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.