(56 days)
Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.
DD cubeX2 is a semi-finished dental blank made of yttrium stabilized pre-sintered zirconium dioxide, which has a super high translucency. The ceramics is of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-178). The DD cubeX2 dental blanks are designed for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or hand-operated copy milling machines. The material is suited ideally for bridges up to 3 elements for both, the anterior and posterior region. The accessories comprises the DD Bio ZX2 monolith zero, which is a coloring fluid for zirconia restorations made from yttrium stabilized pre-sintered zirconium dioxide of different degree of translucency.
The provided text is related to a 510(k) premarket notification for a dental device, "DD cubeX2 and accessories," which is a semi-finished dental blank made of yttrium stabilized pre-sintered zirconium dioxide. The document seeks to establish substantial equivalence to a predicate device, "DD Bio Z-transpa" (K093748).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a table comparing the "Modified product" (DD cubeX2) with the "Unmodified product" (DD Bio Z-transpa) and includes physical and chemical properties tested against the ISO 6872 standard.
| Acceptance Criteria (ISO 6872 Clause/Description) | Required Value (ISO 6872) | Reported Device Performance (DD cubeX2) | Passed/Failed |
|---|---|---|---|
| Uniformity of the material (5.1) | n.a. (visual inspection) | - | Passed |
| Freedom from extraneous materials (5.2.1) | n.a. (visual inspection) | - | Passed |
| Activity concentration of uranium 238 (5.2.2) | 500 MPa | > 720 MPa | Passed |
| Chemical solubility | 720 (Modified) | > 720 MPa | n/a (comparison) |
| E modulus | > 210 GPa | > 210 GPa | n/a (comparison) |
| Density (after sintering) | > 6.0 g/cm³ | > 6.0 g/cm³ | n/a (comparison) |
| CTE (25-500 °C) | 11 [10-6K-1] | 10 [10-6K-1] | n/a (comparison) |
| Fracture toughness | unknown (Unmodified) | 4.8 [MPa * m1/2] | n/a (comparison) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set for the physical and chemical property tests. It mentions that "DD Bio ZX2 monolith zero colored and then sintered DD cubeX2 finished products were tested by an accredited testing laboratory" for biocompatibility and that "Non-clinical testing was performed in order to validate the product against the company's specified design requirements."
- Data Provenance: The testing was performed by an "accredited testing laboratory." The manufacturer, Dental Direkt GmbH, is based in Germany. The document doesn't specify if the testing was retrospective or prospective, but typically non-clinical device testing for regulatory submission is designed prospectively for that purpose.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the ground truth for this device is based on objective physical and chemical measurements according to international standards (e.g., ISO 6872), not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable as the ground truth for this device is based on objective physical and chemical measurements according to international standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a dental material, not a diagnostic tool requiring human interpretation for its primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed in the sense that the device's physical and chemical properties were tested directly against established international standards (ISO 6872 and EN ISO 10993). There is no "algorithm" or "human-in-the-loop" component in the performance evaluation of the dental material itself. The tests relate to the material's inherent properties.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is based on objective, internationally recognized standards and specifications for dental ceramic materials (e.g., ISO 6872:2008, Dentistry Ceramic materials; EN ISO 10993-1, -5 for biocompatibility). These standards define acceptable ranges and methodologies for determining material properties like flexural strength, chemical solubility, and biocompatibility.
8. Sample Size for the Training Set:
This information is not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."
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.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.