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BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.

BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for the BLO₂X Oxygen Blocker.

The document is a 510(k) summary for a dental device, "BLO₂X Oxygen Blocker," which describes its intended use, technological characteristics, and comparison to a predicate device (DeOx®) to demonstrate substantial equivalence. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
4. The type of ground truth used, or sample size and ground truth establishment for a training set.

The document focuses on establishing substantial equivalence to a legally marketed predicate device based on intended use and technological characteristics, rather than presenting a performance study with specific acceptance criteria.

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