510(k) K053166
K053166 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals Limited for the device "SINCLAIR ORAL RINSE". The FDA issued a decision of Substantially Equivalent on May 17, 2006. The device falls under product code NTO (Rinse, Oral, Antibacterial (By Physical Means)), a Class II device regulated under 21 CFR 872.5580. Sinclair Pharmaceuticals Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2006
- Date Received
- November 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rinse, Oral, Antibacterial (By Physical Means)
- Device Class
- Class II
- Regulation Number
- 872.5580
- Review Panel
- DE
- Submission Type
Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.