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510(k) Data Aggregation
(166 days)
- 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.
- 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
- 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.
- 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.
- 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 < 5%") are not explicitly given as such, but rather the performance is demonstrated to be comparable to or within the range of the predicate device.
| Test Item | Acceptance Criteria (Implied by Predicate/Standard) | CharmFlex® Heavy/Regular/Light Performance (Subject Device) | CharmFlex® Putty Performance (Subject Device) | CharmFlex® Bite Performance (Subject Device) |
|---|---|---|---|---|
| Bench Tests | ||||
| Appearance | Complies with general aesthetic and structural integrity expectations for impression materials (not explicitly quantified but passed). | Pass | Pass | Pass |
| Weight | Complies with general weight expectations for impression materials (not explicitly quantified but passed). | Pass | Pass | Pass |
| Component | Complies with general component specifications for impression materials (not explicitly quantified but passed). | Pass | Pass | Pass |
| Working time | ISO 4823/Comparable to predicate (e.g., 1'30" - 2'30" for Light/Medium/Heavy, 1.30min - 2min for Putty, 30-45sec for Bite) | Heavy cartridge: 1'30"; Heavy tube: 2'; Regular/Denture/Light: 2'~2'30" | 1'~1' 30" (26 °C) | 20~35sec (23 °C) |
| Minimum strength | ISO 4823/Comparable to predicate (e.g., ~50-65 for Light/Medium/Heavy, ~62-75 for Putty, ~88-89 for Bite) | 55~65; Heavy (62±2) | 65~85 | 89±2 |
| Hardness | ISO 4823/Comparable to predicate | Not explicitly listed, but implied by Mechanical Strength | Not explicitly listed, but implied by Mechanical Strength | Not explicitly listed, but implied by Mechanical Strength |
| Linear dimensional change | ISO 4823/Comparable to predicate (e.g., 22-30 μm for impression materials, 1.5-2 μm for bite registration) | 20 μm | 30 μm | 1.5 μm |
| Consistency | ISO 4823/Comparable to predicate (e.g., 33-48mm for impression materials, 26-30mm for putty/bite) | 48mm; Heavy (34.25mm) | 25.83mm | 32mm |
| Detail reproduction | ISO 4823/No specific numerical value provided, but presumably meets the standard for impression materials. | Pass | Pass | Pass |
| Compatibility with gypsum | ISO 4823/Comparable to predicate (e.g., 20-30 μm) | 20 μm | 30 μm | 1.5 μm |
| Elastic recovery | ISO 4823/No specific numerical value provided, but presumably meets the standard for impression materials. | Pass | Pass | Pass |
| Strain-in-compression | ISO 4823/Comparable to predicate (e.g., 4.0-5.0% for impression materials, 3.0-4.0% for putty, 1.5-2.5% for bite) | 4.0~5.0% | 3.0~4.0% | 1.5~2.5% |
| Flow properties | Comparable to predicate (e.g., Low/High viscosity for impression, High viscosity for putty/bite) | Low viscosity; Heavy (high viscosity) | High viscosity | High viscosity |
| Viscosity | Comparable to predicate (e.g., 30-48mm for impression, 25-32mm for putty/bite) | 48mm; Heavy (34.25mm) | 25.83mm | 32mm |
| Wettability | Comparable to predicate (e.g., High/Low) | High; Heavy (Low) | Low | Low |
| Setting time | Comparable to predicate (e.g., 2'-4' for impression, 2.22'-4' for putty, 30-60sec for bite) | 2'~4' | 2.22'~4' | 30~60sec |
| Working humidity | Comparable to predicate (50%±10) | 50±10% | 50%±10 | 50%±10 |
| Safety | Demonstrated to be safe through biocompatibility testing. | Safe | Safe | Safe |
| Keeping qualities | Cooler and dry storage conditions comparable to predicate (18-24 °C/64-75 °F) | Cool and dry place (18 | Cool and dry place (18 | Cool and dry place (18 |
| Curve of the shrinkage | No data for both subject and predicate devices, so equivalence is claimed on lack of difference. (Not an acceptance criterion per se, but a reported comparison). | No data | No data | Brittle feature |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing for performance data and biocompatibility testing. However, it does not specify the sample size used for any of these tests.
The data provenance is from Dentkist, Inc., which is located in Gunpo-si, Gyeonggi-do, Korea. The study described is a retrospective analysis of the device's performance against established standards and predicate devices (as implied by a 510(k) submission primarily comparing new device data to existing ones). There is no mention of prospective clinical studies with human participants that would generate new patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For bench test data, ground truth is typically established by the test methods and instruments specified in the ISO standards, not by expert consensus in the typical sense of clinical image interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes bench testing and biocompatibility assessments, not a study requiring adjudication of expert interpretations of data (e.g., medical images).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is an impression material, and the evaluation is based on physical and chemical properties and biocompatibility, not on human interpretation of data (e.g., diagnostic images).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or AI software. It is a physical dental impression material. The described tests are "standalone" in the sense that they are independent evaluations of the material's properties according to established standards.
7. Type of Ground Truth Used:
The "ground truth" for the performance data (e.g., mechanical strength, dimensional accuracy) is based on International Standards (ISO 4823) and potentially ASTM 1980 for shelf-life, as well as previous clearances (predicate devices) for comparison. For biocompatibility, the ground truth is established by the methods outlined in ISO 10993-5 and ISO 10993-10. In essence, the ground truth is defined by established scientific and regulatory standards and the performance of legally marketed equivalent devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept does not apply to the evaluation of this physical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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