One-Fil LC
510(k) K261728
One-Fil LC is a Class II device made by MEDICLUS Co., Ltd., cleared under FDA 510(k) K261728 on 21 Jul 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261728 | Date21 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EJK
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3250
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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