Clearance Summary
PERIO-TEST received FDA 510(k) clearance under submission number K872215, sponsored by Dr. Bernard Loewenthal. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-07-10.
- Submission: K872215
- Applicant / Sponsor: Dr. Bernard Loewenthal
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-07-10
Classification & Regulation
This clearance is catalogued under FDA product code EIL and 21 CFR 872.4565, within the Dental review panel as a Class I device.