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510(k) Data Aggregation
(106 days)
LIGHT CURE RETAINER
L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.
L.C.R."" is a light-cure orthodontic adhesive that is flowable and a highly filled resin in order to provide durability. These properties make it ideal for bonding lingual retainers, creating occlusal buildups and for the retention of a thermoplastic aligner.
L.C.R is available in push syringe, luer-lok syringe or tips for preferences in dispensing.
This document is a 510(k) summary for a medical device called L.C.R.™, a light-cure orthodontic adhesive. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, Flowtain™.
Here's an analysis of the acceptance criteria and the study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (from Predicate Device) | L.C.R.™ Reported Performance |
|---|---|---|
| Intended Use | Light Cure adhesive for bonding lingual retainers, and retention of thermoplastic aligners | Light Cure adhesive for bonding lingual retainers, creation of occlusal buildups and retention of thermoplastic aligners |
| Mechanical / Physical Properties | Flowable Composite Light Cure | Flowable Composite Light Cure |
| Storage | Room Temperature | Room Temperature |
| Shelf Life | 2 years | 2 years |
| Delivery | Syringe | Syringe and Tips |
| Flexural Strength | Performance consistent with ISO 4049:2009 requirements | Performance consistent with ISO 4049:2009 requirements (tested via ISO 4049:2009(E)) |
| Depth of Cure | Performance consistent with ISO 4049:2009 requirements | Performance consistent with ISO 4049:2009 requirements (tested via ISO 4049:2009(E)) |
| Bonding of Lingual Retainers | Successful bond of wire to tooth withstanding multidirectional force | Successful bond of wire to tooth withstanding multidirectional force |
| Bonding of Thermoplastic Aligners | Adhesive created retentive surface for thermoplastic aligner. | Adhesive created retentive surface for thermoplastic aligner. |
| Compressive Strength (for occlusal buildups) | (Implicitly, "effective" performance for the intended use) | "Acceptable results were obtained" |
| Oral Toxicity | (Implicitly, no significant toxicity) | "no significant evidence of toxicity" |
2. Sample Size Used for the Test Set and Data Provenance
- Flexural Strength & Depth of Cure: The document states "L.C.R.™ was tested and compared to Flowtain™ for Flexural Strength and Depth of Cure via ISO 4049:2009(E) test method." While the standard ISO 4049:2009(E) specifies methodology, the exact sample size used for this specific study is not explicitly mentioned in the provided text.
- Compressive Strength: "five replicates" were conducted for the Compressive Strength Test.
- Oral Toxicity: "a 10 Mouse, 7 Day Method (Solid)" was used.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of material property testing, these would typically be laboratory-based prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a "ground truth" in the traditional sense of clinical outcome assessment for the performance tests (Flexural Strength, Depth of Cure, Compressive Strength, Oral Toxicity). These are objective, quantitative laboratory measurements.
For the "Bonding of Lingual Retainers" and "Bonding of Thermoplastic Aligners" properties, the descriptions ("Successful bond," "Adhesive created retentive surface") suggest qualitative assessments, but no information about experts or their qualifications is provided.
4. Adjudication Method for the Test Set
Not applicable. The reported tests are primarily objective laboratory measurements rather than subjective assessments requiring adjudication.
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 an orthodontic adhesive, not an AI software or imaging interpretation tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device (an adhesive), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (Flexural Strength, Depth of Cure, Compressive Strength) is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ISO 4049:2009(E)). For oral toxicity, the ground truth is established by the observed biological response in the mouse model. For bonding efficacy, the "successful bond" or "retentive surface" acts as a qualitative ground truth.
8. The Sample Size for the Training Set
Not applicable. This is a physical product, not a machine learning model, so there is no training set in the AI sense. The development of the adhesive likely involved internal R&D tests, but these are not described as a "training set."
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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