Clearance Summary
DENT-TEMP ACRYLIC received FDA 510(k) clearance under submission number K972198, 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 1997-12-17.
- Submission: K972198
- Applicant / Sponsor: Health-Dent Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 1997-12-17
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.