Clearance Summary
DISPOSABLE PERIODONTAL PROBE received FDA 510(k) clearance under submission number K871504, sponsored by Periodontal Health Brush, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-05-06.
- Submission: K871504
- Applicant / Sponsor: Periodontal Health Brush, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-05-06
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.