Clearance Summary
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM received FDA 510(k) clearance under submission number K882759, sponsored by Viadent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-08-12.
- Submission: K882759
- Applicant / Sponsor: Viadent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1988-08-12
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.