| Device |
rinse, oral, antibacterial (by physical means) |
| Regulation Description |
Oral rinse to reduce the adhesion of dental plaque. |
| Definition |
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. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | NTO |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.5580
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
