510(k) K140202
K140202 is an FDA 510(k) premarket notification submitted by Jiangsu Trausim Medical Instrument for the device "TRAUSIM DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 12, 2014. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2014
- Date Received
- Jan 27, 2014
- Clearance Type
- Traditional
- 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)