Clearance Summary
BREATH ACE BREATHFRESHENER received FDA 510(k) clearance under submission number K972131, sponsored by Beyond 21st Century, 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 1997-07-18.
- Submission: K972131
- Applicant / Sponsor: Beyond 21st Century, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1997-07-18
Classification & Regulation
This clearance is catalogued under FDA product code LCN and 21 CFR 872.6855, within the Dental review panel as a Class I device.