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The provisional inlay and onlay materials are light-curing composites for:

• temporary care of inlay and onlay preparations
• temporary obturation of implant screw access canals
• relining material for prefabricated crowns
• temporary (light cured) cement
• individualization of splints
• forming aids for matrices
• bite registration

FitInspector is an addition-curing silicone for:

• control of precision of fit, marginal adaption and marginal gaps of:
  • inlays / onlays;
  • crowns and bridges;
  • cast metal cores, crowns;
  • metal denture bases; and
• provisional cement for inlays, onlays, crowns and bridges

The Provisional Inlay and Onlay materials are light-curing composites. FitInspector is an addition-curing silicone.

This 510(k) summary is for a Provisional Inlay/Onlay Kit and a component called FitInspector. The submission is a request for substantial equivalence based on predicate devices. It does not contain an independent study with new performance data against acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is an explanation of why and what can be extracted:

• No new performance data or acceptance criteria are presented: The document states, "This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff; while Composites - Premarket Notification (November 1998)." This means the submission relies on demonstrating that the device is substantially equivalent to already approved predicate devices, rather than presenting new performance data against pre-defined acceptance criteria for the new device.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set and qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific study of this device.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information that can be extracted:

1. Device and Predicate Devices:

2. Type of Study:

• Abbreviated 510(k): The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against pre-defined acceptance criteria. It refers to FDA guidance documents: "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" and "Guidance for Industry and FDA Staff; while Composites - Premarket Notification (November 1998)."

Conclusion from document:

"Based on the indications for use, technological characteristics, and comparison to the predicate device, the Provisional Inlay/Onlay Kit has been shown to be safe and effective for its intended use."

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