Search Results
Found 1 results
510(k) Data Aggregation
(318 days)
Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
The acceptance criteria and study proving device performance are detailed below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K053427 Fresh Bold) | Reported Device Performance (Dynax® clear, putty, heavy body, light, mono) |
|---|---|---|
| Working / Processing time | 90 - 120 sec | 90 sec |
| Setting time / Time in the mouth | 120 - 140 sec | 90 sec |
| Hardness | 42 - 70 Shore A | 46 - 70 Shore A |
| Working humidity | 50 % | 50 % |
| Dimensional accuracy | 99.9 % - 99.2 % | 99.9 % - 99.2 % |
| Stability (linear dimensional change) | < 0.1 % typical | < 0.2 % typical |
| Consistency | Type 0 - type 3 DIN EN ISO 4823 | Type 0 - type 3 DIN EN ISO 4823 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "a series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life" and that the device meets its product specification.
The data provenance is not explicitly mentioned as country of origin, but the manufacturer is Dreve Dentamid GmbH, located in Unna/Germany. The testing appears to be "in-house."
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. The testing described focuses on physical and chemical properties of the impression material, not on interpretations by experts.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are not applicable or mentioned, as the testing relates to measurable physical properties rather than subjective interpretations by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document presents a comparison of physical and chemical properties of the device with a predicate device. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The device is a dental impression material, not an algorithm or AI. Performance is evaluated based on its physical properties.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by standardized physical and chemical property measurements, benchmarked against the acceptable ranges defined by the predicate device and relevant international standards (e.g., ISO 4823). These are objective measurements rather than expert consensus, pathology, or outcomes data in a medical diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable and is not provided. The development and testing of this dental impression material do not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device. The ground truth for the product's performance is derived from its adherence to documented specifications and international standards for dental impression materials.
Ask a specific question about this device
Page 1 of 1