(63 days)
Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances.
Flexicast Prime ( Partial Denture Dental Casting Alloy )
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental casting alloy named "Flexicast Prime."
It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study, sample sizes, data provenance, expert qualifications, or ground truth establishment.
- Information on MRMC studies or standalone algorithm performance.
The letter explicitly states that it is a response to the premarket notification submission and that "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market." This type of document typically does not elaborate on the specific performance studies that were submitted to demonstrate substantial equivalence, but rather notifies the applicant of the FDA's decision.
§ 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.