meddevicedb.com FDA Device Reference

Any-Com Seal

K260819 Class II Traditional
Decision Date
2026-05-01
Sponsor / Applicant
Mediclus Co., Ltd.

Technical Specification

510(k) Submission ID K260819
Product Code EBC
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3765
Decision Date 2026-05-01
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Any-Com Seal received FDA 510(k) clearance under submission number K260819, sponsored by Mediclus Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-05-01.

Classification & Regulation

This clearance is catalogued under FDA product code EBC and 21 CFR 872.3765, within the Dental review panel as a Class II device.