Clearance Summary
SPRYCE, DENTURE CLEANSER received FDA 510(k) clearance under submission number K820020, sponsored by Richardson-Vicks, 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 1982-01-22.
- Submission: K820020
- Applicant / Sponsor: Richardson-Vicks, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3520
- Decision date: 1982-01-22
Classification & Regulation
This clearance is catalogued under FDA product code EFT and 21 CFR 872.3520, within the Dental review panel as a Class I device.