510(k) K130601
K130601 is an FDA 510(k) premarket notification submitted by Novocol, Inc. for the device "BIOROOT RCS". The FDA issued a decision of Substantially Equivalent on October 17, 2013. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Novocol, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2013
- Date Received
- March 7, 2013
- Clearance Type
- Abbreviated
- 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