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| | Dental Noble Metal Alloys - Class II Special Controls Guidance Document: (Site not responding. Last check: 2007-10-09) |
 | | A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to metal crown and bridge restorations. |
 | | The special control for this device is the FDA’s “Class II Special Controls Guidance Document: Dental Noble Metal Alloys; Guidance for Industry and FDA.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9. |
 | | A dental noble metal alloys may be primarily composed of gold, silver, platinum, or palladium, with lesser amounts of other elements such as copper and zinc. |
| www.fda.gov /cdrh/ode/guidance/1415.html (1601 words) |
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