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DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device, "Dentca Denture Base II." It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory requirements.

However, the document DOES NOT contain information about:

• Acceptance criteria for device performance.
• Any study that proves the device meets specific acceptance criteria.
• Sample sizes used for testing or training.
• Information on data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical performance validation studies often associated with AI/ML-driven medical devices that would require such information.

Therefore, I cannot provide the requested information based on the given text.

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