Clearance Summary
DENT-DR. VACU-FRAME received FDA 510(k) clearance under submission number K851045, sponsored by Dent-Dr.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-04-22.
- Submission: K851045
- Applicant / Sponsor: Dent-Dr.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1985-04-22
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.