21 CFR 872.3060 — Applicator, Rapid Wax, Dental
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3060
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EIT | Applicator, Rapid Wax, Dental | 2 | 1 | |
| EJS | Alloy, Other Noble Metal | 2 | 194 | |
| EJT | Alloy, Gold-Based Noble Metal | 2 | 627 |
Special Controls
EIT — Applicator, Rapid Wax, Dental
*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.
eCFR
EIT — Applicator, Rapid Wax, Dental
The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.”
Ecfr Llm
EJS — Alloy, Other Noble Metal
*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.
eCFR
EJT — Alloy, Gold-Based Noble Metal
*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.
eCFR
