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Found 3 results
510(k) Data Aggregation
(88 days)
A temporary cement for fixing dental bridges, temporary crowns or bridges, and all metal, porcelain and acrylic crowns.
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This document is a 510(k) premarket notification letter from the FDA regarding the "Fixobridge 3-Cement" device. It primarily discusses the substantial equivalence of this dental cement to legally marketed predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance studies with acceptance criteria.
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(60 days)
For cementing crowns, bridges, onlays, inlays and orthodontic bands.
Caution; US Federal Law restricts this device to sale by or on the order of a dental professional.
Labels will bear this caution.
AHL Generic Glass Ionomer Luting Cement
The provided text is a 510(k) premarket notification letter from the FDA for a dental cement. It does not contain information about the acceptance criteria and study proving device performance as requested. Such details would typically be found in the manufacturer's 510(k) submission, specifically sections related to performance data.
Therefore, I cannot provide the requested information based on the given text.
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(64 days)
INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
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This document is a 510(k) clearance letter from the FDA for a dental cement product. It is a regulatory approval document and does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices, where performance metrics like sensitivity, specificity, or AUC are critical and established through rigorous studies.
This document, however, pertains to a traditional medical device (dental cement) where "performance" is assessed through different means, often involving material properties and clinical experience, not through the kind of statistical analysis of a test set with ground truth that your questions imply.
Therefore, I cannot provide answers to your specific questions based on the provided text.
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