Clearance Summary
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS received FDA 510(k) clearance under submission number K091964, sponsored by Procter & Gamble Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-09-24.
- Submission: K091964
- Applicant / Sponsor: Procter & Gamble Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 2009-09-24
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.