EIT · Applicator, Rapid Wax, Dental
Dental · 21 CFR 872.3060 · Class 2
Overview
| Product Code | EIT |
|---|---|
| Device Name | Applicator, Rapid Wax, Dental |
| Regulation | 21 CFR 872.3060 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
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.
Classification Rationale
Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
Special Controls
*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904467 | ARGILITE 3 | Argen Precious Metals, Inc. | Oct 31, 1990 | SESE |
Top Applicants
- Argen Precious Metals, Inc. — 1 clearance
