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
| Device Type ID | 1375 |
| Device Name | Dental Amalgam |
| 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 Description | Dental Amalgam, Mercury, And Amalgam Alloy. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.3070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 1375 |
| Device | Dental Amalgam |
| Product Code | OIV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dental Amalgam, Mercury, And Amalgam Alloy. |
| CFR Regulation Number | 872.3070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NEW STETIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |