Clearance Summary
HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT received FDA 510(k) clearance under submission number K861846, sponsored by Solar Dental Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-06-26.
- Submission: K861846
- Applicant / Sponsor: Solar Dental Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-06-26
Classification & Regulation
This clearance is catalogued under FDA product code EIC and 21 CFR 872.4565, within the Dental review panel as a Class I device.