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 |
Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
880.6375
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|