Clearance Summary
PROFLEX FLEXIBLE SCALER received FDA 510(k) clearance under submission number K821364, sponsored by Teledyne Densco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-05-28.
- Submission: K821364
- Applicant / Sponsor: Teledyne Densco
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6010
- Decision date: 1982-05-28
Classification & Regulation
This clearance is catalogued under FDA product code EHM and 21 CFR 872.6010, within the Dental review panel as a Class I device.