Clearance Summary
DIAMOND D HIGH IMPACT DENTURE ACRYLIC received FDA 510(k) clearance under submission number K032773, sponsored by Mycone Dental Supply Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-09-23.
- Submission: K032773
- Applicant / Sponsor: Mycone Dental Supply Co., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2003-09-23
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.