510(k) K111935
K111935 is an FDA 510(k) premarket notification submitted by Nt-Trading GmbH And CO KG for the device "TI-BASE ABUTMENT, 1 CONNECT ABUTMENT". The FDA issued a decision of Substantially Equivalent on Feb 17, 2012. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2012
- Date Received
- Jul 8, 2011
- 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.