510(k) K130312
K130312 is an FDA 510(k) premarket notification submitted by Innovative Bioceramix, Inc. for the device "IROOT FM". The FDA issued a decision of Substantially Equivalent on Sep 18, 2014. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Innovative Bioceramix, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 18, 2014
- Date Received
- Feb 7, 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
- 510(k)