| Device |
impression material for fabrication of patient-matched mouthguards, over-the-counter |
| Regulation Description |
Impression material. |
| Definition |
An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards. |
| Physical State |
The impression material in Type 0, high viscosity, elastomeric, polyvinylsiloxane (VPS or PVS) material consisting of a two-component system (base and catalyst putty) in jars. |
| Technical Method |
The impression material is a Type 0, high viscosity, elastomeric material consisting of a two-component system (base and catalyst putty) in jars, mixed by hand, and placed on an impression tray. The user bites down on the putty in the tray to take an impression of teeth and gums. |
| Target Area |
Oral Cavity |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | SHI |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.3660
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
