Clearance Summary
VISIO-SEAL received FDA 510(k) clearance under submission number K811624, sponsored by Espe-Premier Sales Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-06-26.
- Submission: K811624
- Applicant / Sponsor: Espe-Premier Sales Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 1981-06-26
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.