Clearance Summary
VIP VICTOR INTERACTIVE PROBE received FDA 510(k) clearance under submission number K960245, sponsored by Pro-Dentec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-04-04.
- Submission: K960245
- Applicant / Sponsor: Pro-Dentec
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1996-04-04
Classification & Regulation
This clearance is catalogued under FDA product code EIX and 21 CFR 872.4565, within the Dental review panel as a Class I device.