510(k) DEN050001
DEN050001 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals Limited for the device "DECAPINOL ORAL RINSE". The FDA issued a decision of De Novo Granted on April 18, 2005. 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
- DENG (De Novo Granted)
- Decision Date
- April 18, 2005
- Date Received
- January 24, 2005
- Clearance Type
- Post-NSE
- 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.