510(k) K231259
K231259 is an FDA 510(k) premarket notification submitted by Innovative Bioceramix, Inc. for the device "iRoot SP Plus". The FDA issued a decision of Substantially Equivalent on May 31, 2023. 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
- May 31, 2023
- Date Received
- May 1, 2023
- Clearance Type
- Special
- 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)