Clearance Summary
DENTAL PLAQUE DISCLOSING AGENT received FDA 510(k) clearance under submission number K770990, sponsored by Evident Dental Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-06-20.
- Submission: K770990
- Applicant / Sponsor: Evident Dental Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1977-06-20
Classification & Regulation
This clearance is catalogued under FDA product code QJC and 21 CFR 872.6855, within the Dental review panel as a Class I device.