(58 days)
Artic line are artificial synthethic resin permanent teeth. The enamel and dentine layers of HK teerh are highly cross-linked and suit the rate of natural abrasion, The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic
Artic artificial resin teeth are compatible with all denture base resins. If necessary special instructions for the bonding to denture base resins are included in the users instruction of the denture base.
The provided text describes a 510(k) premarket notification for a dental device, "Artic" preformed plastic denture teeth. This document details the regulatory approval process for the device, stating its substantial equivalence to previously cleared predicate devices (JelDent Basic and JelDent Premium).
However, the provided text does not contain information regarding an acceptance criteria table, device performance data, detailed study designs, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is purely a regulatory submission and approval letter, focusing on the device's classification, intended use, and substantial equivalence to existing products. It explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the evidence for substantial equivalence was likely based on comparing the new device's specifications and materials to the already cleared predicate devices, rather than an independent performance study with acceptance criteria as requested in the prompt.
Therefore, I cannot provide the requested information from the given text. While it confirms the device's regulatory acceptance, it does not include the details of a study that proves it meets specific performance acceptance criteria in the manner typically associated with efficacy studies for AI/medical imaging devices.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). 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.