ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH

• K Number: K013824
• Device Name: ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
• Manufacturer: DENTAL MANUFACTURING S.P.A
• Date Cleared: 2002-01-30 ( 72 days)
• Product Code: ELM
• Regulation Number: 872.3590
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V and Z-TONE Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

Device Description

prefabricated devices, composed of methyl methacrylate material

AI/ML Overview

I am sorry, but this document is a letter from the FDA regarding the substantial equivalence of denture teeth. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies for an AI/ML device. Therefore, I cannot generate the requested output based on the provided text.

Regulation Number and Section

§ 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.