| Device |
dental amalgam |
| Regulation Description |
Dental amalgam, mercury, and amalgam alloy. |
| Definition |
Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth. |
| Physical State |
Powder and liquid metals encapsulated and separated by a septum. Forms a solid upon mixing. |
| Technical Method |
Heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material |
| Target Area |
Direct filling of teeth. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | OIV |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.3070
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
