510(k) K770990
K770990 is an FDA 510(k) premarket notification submitted by Evident Dental Co. , Ltd. for the device "DENTAL PLAQUE DISCLOSING AGENT". The FDA issued a decision of Substantially Equivalent on June 20, 1977. The device falls under product code QJC (Plaque Disclosing Agent), a Class I device regulated under 21 CFR 872.6855.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1977
- Date Received
- May 31, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plaque Disclosing Agent
- Device Class
- Class I
- Regulation Number
- 872.6855
- Review Panel
- DE
- Submission Type
Intended to enhance visualization of the presence of plaque on tooth surfaces.