Clearance Summary
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR received FDA 510(k) clearance under submission number K943182, sponsored by Oral-B Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-09-09.
- Submission: K943182
- Applicant / Sponsor: Oral-B Laboratories
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1994-09-09
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.