Clearance Summary
MODEL 6110B DENTAPHOR received FDA 510(k) clearance under submission number K870118, sponsored by Life-Tech 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 1987-04-10.
- Submission: K870118
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1720
- Decision date: 1987-04-10
Classification & Regulation
This clearance is catalogued under FDA product code EAT and 21 CFR 872.1720, within the Dental review panel as a Class II device.