510(k) K212283
K212283 is an FDA 510(k) premarket notification submitted by Septodont for the device "BioRoot Flow 0.5g, BioRoot Flow 2g". The FDA issued a decision of Substantially Equivalent on September 16, 2021. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Septodont has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2021
- Date Received
- July 21, 2021
- 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