510(k) K161857
K161857 is an FDA 510(k) premarket notification submitted by Salvin Dental Specialties for the device "Salvin Tenting Screw System". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Salvin Dental Specialties has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2017
- Date Received
- July 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type