| Device |
oral lubricant |
| Regulation Description |
Patient lubricant. |
| Definition |
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; placement of a rubber dam; and to prevent the lips from drying and cracking during dental procedures. |
| Physical State |
viscous liquid or gel |
| Technical Method |
direct application |
| Target Area |
oral hard and soft tissue |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
Dental |
|---|
| Product Code | ONK |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6375
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
