Clearance Summary
ULTRA-WET received FDA 510(k) clearance under submission number K820216, sponsored by Buffalo Dental Mfg. Co., 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 1982-02-24.
- Submission: K820216
- Applicant / Sponsor: Buffalo Dental Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1982-02-24
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.