Clearance Summary
PRE-DENT SYSTEM OR PRE-DENT II received FDA 510(k) clearance under submission number K801386, sponsored by Pre-Dent System. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-07-14.
- Submission: K801386
- Applicant / Sponsor: Pre-Dent System
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.9050
- Decision date: 1980-07-14
Classification & Regulation
This clearance is catalogued under FDA product code KSS and 21 CFR 864.9050, within the Hematology review panel as a Class I device.