Search Results

EASY GLAZE is intended for the following applications:

1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
2. Sealing the adhesive interfaces between restoration and tooth structure.
3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
4. Sealing glass ionomer cement liners/build-up restorations before taking impressions.

EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.

The provided text is a 510(k) Summary for a dental device called "EASY GLAZE". This document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets them.

Here's a breakdown of why the requested information isn't fully available and what can be inferred:

The core argument for the "EASY GLAZE" device is that all of its components are found in legally marketed predicate devices. This approach (often called "component-based substantial equivalence") implies that if the components are safe and effective in other approved devices, the new device using those same components will also be safe and effective for its stated intended use.

Therefore, many of the requested criteria related to a dedicated performance study with specific acceptance criteria, sample sizes, expert ground truth, etc., are not present in this type of 510(k) submission.

Here's an attempt to answer your questions based on the provided text, highlighting what is not applicable or not disclosed:

Acceptance Criteria and Study for EASY GLAZE

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance tests. The implicit acceptance criterion is "substantial equivalence" to the predicate devices.
• Reported Device Performance: The primary "performance" reported is the assertion that "The prior use of all of the components of EASY GI.AZE in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." This indicates that the performance is benchmarked against the established performance of its components in predicate devices. No specific quantitative performance metrics (e.g., bond strength, wear resistance) are provided for EASY GLAZE itself in this summary.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not applicable/not disclosed. No dedicated "test set" for a performance study of the final EASY GLAZE formulation is mentioned because the argument relies on component equivalence.
• Data Provenance: Not applicable. The "data" used is the regulatory history and prior approval of the components in other devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable/not disclosed. Ground truth establishment for a new performance study is not described.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable.

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:

• MRMC Study: Not applicable. This device is a dental coating, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used:

• Ground Truth: For the purpose of this 510(k), the "ground truth" implicitly relies on the established safety and effectiveness of the individual components of EASY GLAZE, as demonstrated by their prior approval in the predicate devices (K052462, K043168, K974772, K070306). There is no "ground truth" derived from a new, independent study of EASY GLAZE's performance explicitly mentioned.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not a machine learning/AI device, so there is no training set in the typical sense.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable.

Summary of Approach:

This 510(k) summary uses the "substantially equivalent" pathway by arguing that EASY GLAZE is composed entirely of components already found in other legally marketed devices. Therefore, the burden of requiring new, extensive performance studies (which would have specific acceptance criteria, sample sizes, ground truth establishment, etc.) directly on the EASY GLAZE product is reduced. The "study" referenced is essentially the regulatory history and established safety/effectiveness profiles of the individual components and the predicate devices themselves.

Ask a specific question about this device

SURFACE COAT is used to glaze/polish following restorations:

• Direct and indirect composite resins
• Acrylic provisional crowns and bridges
• Acrylic appliances
• Glass ionomers and resin-modified glass ionomers

SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

The provided 510(k) summary for K063228 (SURFACE COAT) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification, which largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for clinical or diagnostic devices.

However, based on the available information, I can extract and infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance."

This indicates that internal specifications were used, but these specific specifications and their corresponding performance metrics are not detailed in this 510(k) summary. It only mentions that the device was tested accordingly and validated against predicate devices for effectiveness and performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified. Since it's a materials science submission, it's highly likely to be laboratory/bench testing data rather than patient data from a specific country, and thus, "retrospective or prospective" would not apply in the typical clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This type of information (experts establishing ground truth) is typical for clinical studies involving diagnosis or interpretation. For a dental material, "ground truth" would likely be established through objective laboratory measurements and material science standards/tests, not expert consensus in the diagnostic sense.
• Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Not applicable/Not specified for this type of material performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for diagnostic devices involving human readers interpreting images or data. It is not relevant for a dental resin glaze material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a material, not a software algorithm.

7. The Type of Ground Truth Used

• For a material like "SURFACE COAT," the "ground truth" would be established by the physical and chemical properties of the material as measured by standardized laboratory methods (e.g., tests for hardness, wear resistance, bond strength, surface smoothness, oxygen inhibition layer thickness).
• The document implies these were internal "specifications" and comparisons to predicate devices for "effectiveness and performance."

8. The Sample Size for the Training Set

• Not applicable/Not specified. The concept of a "training set" is usually for machine learning algorithms. For material development, various formulations and batches might be tested during R&D, but this isn't typically referred to as a "training set" in the context of regulatory submissions for materials.

9. How the Ground Truth for the Training Set was Established

• Not applicable/Not specified.

Summary of Study Information (as inferable from the document):

The submission relies on demonstrating substantial equivalence to predicate devices (BISCOVER LIQUID POLISH, BISCOVER LV, etc.) rather than a full de novo performance study against explicit acceptance criteria.

The study performed was a comparison of the SURFACE COAT's effectiveness and performance characteristics against those of the predicate devices. The exact nature of these tests (e.g., specific mechanical properties tested, methods used) and their quantitative results are not disclosed in this summary. The manufacturer states that "certain specifications are designed for SURFACE COAT...and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent." This implies bench testing to show similar or superior material properties relative to the predicates.

In essence, the "study" for this 510(k) demonstrated that the new device performs sufficiently similar to already approved devices, making it substantially equivalent, without needing to define new, explicit clinical acceptance criteria in the format you requested.

Ask a specific question about this device