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Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3.

DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths.

DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019.

DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed.

DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.

The provided FDA 510(k) clearance letter for DentaTOOTH is for a temporary crown and bridge resin, not an AI-powered diagnostic device. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria (such as MRMC studies, ground truth establishment, expert consensus, etc.) are not applicable to this type of device.

The 510(k) summary clearly states:

• Device Name: DentaTOOTH
• Common Name: Temporary crown and bridge resin
• Classification Name: Crown And Bridge, Temporary, Resin
• Regulation Number: 872.3770 (which corresponds to Temporary Crown And Bridge Resin)
• Product Code(s): EBG

The documentation details non-clinical tests performed in accordance with specific ISO standards relevant to dental materials (ISO 10477:2020 for Polymer-based crown and veneering materials and ISO 4049:2019 for Polymer-based restorative materials). These tests evaluate material properties such as:

• Depth of cure
• Surface finish
• Flexural strength
• Water sorption
• Solubility
• Shade consistency
• Color stability
• Packaging validation
• Shelf life
• Biocompatibility (according to ISO 10993-1:2018)

The clearance is based on the substantial equivalence of DentaTOOTH's material properties and indications for use to legally marketed predicate devices, as demonstrated by these material-specific performance tests.

Therefore, I cannot provide a response to your numbered points as they are designed for the evaluation of AI/ML or diagnostic devices, which is not what DentaTOOTH is.

The questions you posed are typical for the regulatory review of Software as a Medical Device (SaMD) with AI/ML components, particularly those involved in image analysis or diagnosis where performance is measured by metrics like sensitivity, specificity, or reader agreement. DentaTOOTH is a material, not a software or diagnostic device.

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