Clearance Summary
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC received FDA 510(k) clearance under submission number K983876, sponsored by Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-12-16.
- Submission: K983876
- Applicant / Sponsor: Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 1998-12-16
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.