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510(k) Data Aggregation
(38 days)
Rite-Dent Bonding System creates a bond between and all resin restorative materials. It consists of an Aola Lionany of the surface area for mechanical bonding. The The Librant clonod the onamer is interlock the etched area. After placement of Oatalyst and Dubo intinued and the monded enamel, a chemical bond will form between the composite and the tooth structure.
Enamel Bonding System
The provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Enamel Bonding System" manufactured by Rite-Dent Manufacturing Corporation. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.
The letter is a regulatory approval document and focuses on the substantial equivalence determination for market entry, not on the technical performance data that would typically be reported in a clinical or performance study.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.
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(57 days)
This is a chemically activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.
Pit and Fissure Sealant
The provided text is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study. This document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.
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(73 days)
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(81 days)
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(61 days)
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(82 days)
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(81 days)
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