510(k) K241977
K241977 is an FDA 510(k) premarket notification submitted by Longly Biotechnology (Wuhan) Co., Ltd. for the device "Injectable Root Canal Bioceramic Sealer (i-MTA SP)". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Longly Biotechnology (Wuhan) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2024
- Date Received
- July 5, 2024
- 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