(161 days)
DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.
DD medical polymers, made from medical grade, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints (clear variant) on dental CAD/CAM systems.
The document concerns the 510(k) premarket notification for "DD medical polymers" (DD tempMED and DD Bio Splint P) by Dental Direkt GmbH. The device is a resin for temporary crowns, bridges, and bite splints.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from international standards DIN EN ISO 20795-1 and ISO 10477, which pertain to denture base polymers and polymer-based crown and bridge materials, respectively.
| Requirement | Required Value (ISO 20795-1) | Required Value (ISO 10477) | Value Submission Device | Value Predicate Device | Passed / Failed |
|---|---|---|---|---|---|
| Flexural Strength [MPa] | ≥ 65 | ≥ 50 | ≥ 75 | 90 | Passed |
| Flexural Modulus [MPa] | ≥ 2000 | Not specified | 2800 (± 200) | Not specified | Passed |
| Residual MMA Monomer [%] | ≤ 2.2 | Not specified | 0.4 | 1.4 | Passed |
| Water Sorption [µg/mm³] | ≤ 32 | ≤ 40 | ≤ 23 | 23 | Passed |
| Solubility [µg/mm³] | ≤ 1.6 | ≤ 7.5 | 0.2 | 0.0 | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of specimens) used for each mechanical or chemical test. It only mentions that "Finished DD medical polymer products in all variants were tested."
The data provenance is from non-clinical testing performed according to international standards (DIN EN ISO 20795-1 and ISO 10477) and biocompatibility standards (EN ISO 10993-1, -5). These tests were conducted by an accredited, GLP-certified testing laboratory. The country of origin of the data is not explicitly stated beyond the fact that Dental Direkt GmbH is based in Germany and the testing laboratory is accredited. The tests are non-clinical (laboratory-based) and are retrospective in the sense that they are conducted on finished products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided document pertains to a medical device's physical and chemical properties and biocompatibility, not an AI/CADe/CADx system that would require expert-driven ground truth for performance evaluation.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3. The "ground truth" here is defined by the requirements of the international standards themselves, measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance
This information is not applicable as the device is a dental material, not an AI-assisted diagnostic or treatment planning system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by the specified limits set forth in the following international standards:
- DIN EN ISO 20795-1:2013: Dentistry - Base polymers - Part 1: Denture base polymers
- ISO 10477:2004: Dentistry Polymer-based Crown and Bridge Materials
- EN ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (for biocompatibility)
- EN ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (for biocompatibility)
These standards define objective physical, chemical, and biological performance criteria.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical material, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.