(12 days)
Dental impression material for:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
The modified IMPREGUM® PENTA® is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth. ESPE is submitting this Special 510(k) for modifications of its polyether based impression material IMPREGUM® PENTA®. In particular one ingredient will be exchanged by a chemical compound with comparable character and another one will be added.
1. Acceptance Criteria and Device Performance:
The document does not explicitly state quantitative acceptance criteria or device performance metrics for the modified IMPREGUM® PENTA® in a clear table format, as this is a Special 510(k) focused on demonstrating substantial equivalence. Instead, the "acceptance" is based on the material meeting the same fundamental scientific technology, intended use, operating principle, basic chemical design, shelf life, and manufacturing/packaging processes as the predicate device.
2. Sample Size and Data Provenance:
No studies with specific sample sizes of test sets are described. The submission relies on a comparison of the modified and unmodified device characteristics rather than a standalone clinical or performance study with a distinct test set. The data provenance is effectively "internal" to the manufacturer (ESPE Dental AG, Germany), comparing their own modified product to their existing predicate product.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. This type of submission does not involve a test set requiring expert ground truth establishment in the traditional sense of a diagnostic or therapeutic device study. The "ground truth" here is a comparison of product specifications and performance in a manufacturing/testing context.
4. Adjudication Method for the Test Set:
Not applicable, as there is no specifically defined "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic imaging or clinical decision support device where human readers interact with AI.
6. Standalone (Algorithm Only) Performance Study:
Not applicable, as this is an impression material, not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating substantial equivalence relies on:
- Physical and Mechanical Properties: Comparative tests of the material's characteristics (implied, though specific data is not provided in this summary).
- Chemical Composition: Comparison of the components between the modified and unmodified devices.
- Intended Use, Operating Principle, Shelf Life, Manufacturing: Demonstrating consistency with the predicate device.
8. Sample Size for the Training Set:
Not applicable. This product is a medical device (impression material), not an AI algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).