510(k) K130125
K130125 is an FDA 510(k) premarket notification submitted by S&C Polymer Silicon- Und Composite Spezialitaeten for the device "MTA CEMENTS". The FDA issued a decision of Substantially Equivalent on July 24, 2013. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. S&C Polymer Silicon- Und Composite Spezialitaeten has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2013
- Date Received
- January 17, 2013
- 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