(37 days)
This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.
This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.
I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device. The document is an FDA 510(k) clearance letter for a dental alloy named "Continum™ V," confirming its substantial equivalence to a legally marketed predicate device. It addresses regulatory information, marketing authorization, and general compliance requirements, but it does not include performance studies or validation data.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.