510(k) K162661
K162661 is an FDA 510(k) premarket notification submitted by Tyds Biotech Incorporation for the device "SavDenTM MTA Root Canal Filling Materials". The FDA issued a decision of Substantially Equivalent on Apr 25, 2017. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 2017
- Date Received
- Sep 26, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type
- 510(k)