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CharmFil is indicated for following restorative applications.

1. Class I, II, V restorations of posterior teeth
2. Class III, IV, V restorations of anterior teeth
3. Cervical cavities or defects involving root surfaces

This device is light curing dental for dental surgery treatment and type 1, class 2, group 1 according to ISO 4049 classification. It is made in the form of paste and filled in syringe. When you use the product, press out the content in the syringe by screw. It is used to restore a cavity as taking out from it as much as you need with an instrument. It is dental filling material for restoring the cavities.

The acceptance criteria and the study proving the device meets them are outlined below based on the provided text for the CharmFil device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each performance test. The nature of the tests (physical and chemical properties, elution substance, biological safety) suggests that material samples of the CharmFil device were tested in a laboratory setting. The data provenance is not specified beyond indicating that Dentkist, Inc. is located in Gunpo-si, Gyeonggi-do, Korea, implying that the testing likely occurred in South Korea. The study appears to be retrospective, as it's a submission for premarket notification based on completed tests.

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

Not applicable. This device is a dental restorative material, and the acceptance criteria are based on objective physical, chemical, and biological safety standards (ISO 4049). There is no mention of expert readers establishing ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the acceptance criteria are objective and assessed against established international standards (ISO 4049) and biological safety guidelines. There is no qualitative assessment that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The CharmFil device is a dental restorative material, and its performance is evaluated based on material properties and biological safety.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The performance testing described is "standalone" in that it assesses the intrinsic properties and safety of the material itself, without direct human interaction as part of the performance evaluation (beyond conducting the tests).

7. The Type of Ground Truth Used

The "ground truth" for the performance tests consists of established industry standards (e.g., ISO 4049 for physical and chemical properties) and biological safety criteria. These are objective, quantitative or qualitative thresholds that the device's characteristics must meet.

8. The Sample Size for the Training Set

Not applicable. As this device is a dental restorative material and its performance is assessed against standardized material properties and biological safety, there is no "training set" in the context of machine learning or diagnostic algorithm development.

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

Not applicable, as there is no training set.

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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions

CharmFlex is impression material. It has 5 types: Putty, Regular, Light, Heavy, Bite.

1. CharmFlex®Putty/ CharmFlex®Putty Green/ CharmFlex®Putty Soft CharmFlex®Putty consists of various Putty-bodies type and dental addition silicone impression material made by polymerization as a mixture of Base and Catalyst. In dental treatment, an impression material used to record oral tissue anatomy. CharmFlex®Putty has viscosity of putty consistency classification according to type 0 ISO 4823 classification. Packaging consists of two putty systems which are supplied by in two jars, the one is base and another is catalyst. This product is used for two step impression and the material for the first impression is for recording oral tissue anatomy. Base and catalyst of impression are packed separatelv
2. CharmFlex®Heavy cartridge type/ CharmFlex®Heavy tube type CharmFlex® Heavy series are hydrophilic vinyl polysiloxane impression materials type of Heavybodies. It is used for the one-step impressions teeth or individual tooth in the mouth. CharmFlex®Heavy as the additional polymerization silicone type is rubber impression materials that registers oral tissue anatomy. It is used with Light-body for impression taking. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of whole teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials.
3. CharmFlex®Regular/ CharmFlex®Denture/ CharmFlex®Light LV/ CharmFlex®Light XLV/ CharmFlex®Light Premium CharmFlex® Light series are hydrophilic vinyl polysiloxane impression material type of LightLV, Regular and LightXLV. It is used for the one-step or two-step impression taking of teeth or individual tooth in the mouth. CharmFlex® Light XLV/Regular series as the additional polymerization silicone type are rubber impression materials that records oral tissue anatomy. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials.
4. CharmFlex®Bite/ CharmFlex®Bite Clear/ CharmFlex®Bite Fast CharmFlex Bite series are bite registration impression material to measure of the occlusal surface. impression of the teeth for a three-dimension position of the mandible in relation to the maxilla. It has a short polymerization time and a high final hardness. Making it suitable for bite registration.

This document is a 510(k) Summary for the medical device "CharmFlex®", a dental impression material. It seeks to prove substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data for three categories of CharmFlex® products against predicate devices. The acceptance criteria aren't explicitly stated as numerical targets in a separate section, but are implicitly defined by performing the tests against established ISO standards (ISO 4823 for Dentistry-Elastomeric impression materials) and comparing the results to those of legally marketed predicate devices. The "reported device performance" are the values listed for the "Subject Device" in the comparison tables.

Here's a consolidated table, noting that specific numerical acceptance criteria (e.g., "must be

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