Clearance Summary
CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER received FDA 510(k) clearance under submission number K080631, sponsored by Oral Health Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-05-23.
- Submission: K080631
- Applicant / Sponsor: Oral Health Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3520
- Decision date: 2008-05-23
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.