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Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.

It is the intention of S & C Polymer GmbH to manufacture the TRAY-LINK cited above which can be used as adhesive system for adhering silicone impression materials on disposable plastic or light cured custom trays.
The cited TRAY-LINK material S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains a chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist or technician is to build a chemical link between impression materials and the impression trays.
The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483.

This document seems to be a 510(k) premarket notification for a dental adhesive product called TRAY-LINK. It describes the product's purpose, chemical composition, and regulatory information, but it does not contain any information about acceptance criteria, study designs, or performance data for a device in the context of the requested questions.

The provided text focuses on the regulatory submission process and the substantial equivalence to a predicate device (A-Soft Reline K984483). It explicitly states: "The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483." This indicates that the regulatory approval in this case relies on chemical substantial equivalence, not on a new performance study that would generate the kind of data you're asking for.

Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth are not addressed in this 510(k) submission.

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For etching dentin and enamel.

Not Found

This document is a 510(k) premarket notification for a dental etching gel, not a study report detailing performance criteria and results of a device. Therefore, most of the requested information cannot be extracted directly from the provided text.

Based on the information provided:

1. A table of acceptance criteria and the reported device performance: Not available. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance criteria and results from a clinical or analytical study.

2. Sample size used for the test set and the data provenance: Not applicable/Not available. This document does not describe a clinical or analytical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not available.

4. Adjudication method for the test set: Not applicable/Not available.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a chemical product (etching gel), not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an etching gel.

7. The type of ground truth used: Not applicable/Not available for a clinical study. For substantial equivalence, the "ground truth" is that the new device has "substantially similar" chemical composition, intended use, performance, indications, labels, and instructions for use to the predicate device.

8. The sample size for the training set: Not applicable/Not available. This document does not pertain to a machine learning or AI algorithm where a "training set" would be used.

9. How the ground truth for the training set was established: Not applicable/Not available.

Summary based on the provided text:

The document describes the submission of a 510(k) premarket notification for an "ETCHING GEL" manufactured by S & C Polymer GmbH. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, "ETCH GEL" by HENRY SCHEIN.

The key information regarding "acceptance criteria" and "study" in this context is centered around the concept of substantial equivalence as defined by the FDA for medical devices.

• Acceptance Criteria (Implicit for 510(k) clearance): The "acceptance criteria" for 510(k) clearance in this case is that the device, ETCHING GEL, is "substantially equivalent" to a predicate device ("ETCH GEL" by HENRY SCHEIN). This means it must have:

  • The same intended use.
  • The same technological characteristics (or if different, that the differences do not raise new questions of safety and effectiveness).
  • Similar performance, indications, proposed labels, and instructions for use.
  • A chemical composition commonly found in current dental materials.

• Study That Proves the Device Meets Acceptance Criteria: The "study" here is the 510(k) premarket notification process itself, which involves providing documentation to the FDA to demonstrate substantial equivalence. The document states:

  • "The chemical composition and use of ETCHING GEL is substantially equivalent to 'ETCH GEL', a product manufactured and marketed as an own brand by HENRY SCHEIN."
  • "S & C Polymer GmbH's and HENRY SCHEIN's intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached)."

Therefore, the "proof" that the device meets the "acceptance criteria" (of substantial equivalence) is the assertion and supporting documentation within the 510(k) application, which compares the new device to the predicate device across various attributes. This is not a formal clinical trial or performance study as might be conducted for novel, higher-risk devices or software.

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