Clearance Summary
HEMA-GLU received FDA 510(k) clearance under submission number K951220, sponsored by Health-Dent Intl., 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 1995-05-12.
- Submission: K951220
- Applicant / Sponsor: Health-Dent Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1995-05-12
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.