(26 days)
Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Wiedent Esthetic Teeth."
This type of letter primarily focuses on:
- Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
- Regulatory Classification: It clarifies the device's regulatory class and product code.
- Compliance Requirements: It reminds the manufacturer of their ongoing responsibilities under the Federal Food, Drug, and Cosmetic Act.
The document does not include:
- Specific acceptance criteria for the device's performance (e.g., tensile strength, wear resistance, color stability).
- Details of any performance studies conducted to meet such criteria.
- Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot populate the table or provide the requested study details from the text you provided.
§ 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.