Clearance Summary
DENTAL WARM WATER IRRIGATING SYSTEM received FDA 510(k) clearance under submission number K781594, sponsored by Rama Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-12-04.
- Submission: K781594
- Applicant / Sponsor: Rama Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1978-12-04
Classification & Regulation
This clearance is catalogued under FDA product code ECB and 21 CFR 872.4565, within the Dental review panel as a Class I device.