510(k) K150968
K150968 is an FDA 510(k) premarket notification submitted by Sterngold Dental, LLC for the device "TRU Dental Implant System". The FDA issued a decision of Substantially Equivalent on Jul 24, 2015. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold Dental, LLC has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2015
- Date Received
- Apr 13, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)