510(k) K261728
K261728 is an FDA 510(k) premarket notification submitted by Mediclus Co., Ltd. for the device "One-Fil LC". The FDA issued a decision of Substantially Equivalent on July 21, 2026. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Mediclus Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2026
- Date Received
- May 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liner, Cavity, Calcium Hydroxide
- Device Class
- Class II
- Regulation Number
- 872.3250
- Review Panel
- DE
- Submission Type