(682 days)
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
The Aidite Pmma is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 40 specifications for Cylinder model (variation in different diameters and heights), and 24 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 17 various shades of the proposed device: 1 is transparent (without color added), the other 16 shades are colored (with different coloring matters added). The 16 shades created based on 16 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.
The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.
Here's an analysis of the acceptance criteria and study information for the Aidite PMMA device, based on the provided FDA 510(k) summary:
The device in question is "Aidite Pmma", a polymethylmethacrylate (PMMA) material for fabricating temporary crowns and bridges, intended for oral use up to six months while awaiting permanent restoration. Restorations are designed and manufactured by a dental professional using CAD technology.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K141421), rather than setting explicit new performance acceptance criteria with specific numerical targets outside of established ISO standards. Therefore, the "acceptance criteria" are implied by compliance with ISO and ASTM standards and performance being "substantially equivalent" to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Material/Composition | PMMA with cross-linking agents | PMMA with cross-linking agents (Same as predicate) |
| Flexural Strength | ≥ 50 MPa (ASTM F1980, ISO 10477) | ≥ 50 MPa (Same as predicate) |
| Shelf Life | 2 years (Proven by accelerated aging) | 2 years (Predicate has 5 years, but 2 years proven for proposed) |
| Biocompatibility | Compliant with ISO 10993 and ISO 7405 standards | Tested in accordance with ISO 10993-1, -3, -5, -10, -11 and ISO 7405 standards (Acceptance met based on "adequacy" statement in 510k, though specific results not provided) |
| Surface Finish | Compliant with ISO 10477 | Meets acceptance criteria (Specific value not provided) |
| Bond Strength | Compliant with ISO 10477 | Meets acceptance criteria (Specific value not provided) |
| Water Sorption | Compliant with ISO 10477 | Meets acceptance criteria (Specific value not provided) |
| Solubility | Compliant with ISO 10477 | Meets acceptance criteria (Specific value not provided) |
| Shade Consistency | Compliant with ISO 10477 and ISO 7491 | Evaluated and meets acceptance criteria (Specific details not provided) |
| Color Stability | Compliant with ISO 10477 and ISO 7491 | Evaluated and meets acceptance criteria (Specific details not provided) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., biocompatibility sub-tests, mechanical properties). It states that tests were conducted according to specific ISO and ASTM standards. These standards would typically define appropriate sample sizes for each test type.
- Data Provenance: The studies were conducted by Aidite (Qinhuangdao) Technology Co., Ltd. in China. The document does not explicitly state "retrospective" or "prospective" but these are non-clinical performance tests and biocompatibility tests typically performed in a laboratory setting for device clearance, implying they are purpose-built tests for this submission (prospective in that sense).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this type of 510(k) submission. This device is a dental material, and the "ground truth" is established through adherence to international standards for material properties and biocompatibility. There is no concept of "expert consensus ground truth" or "adjudication" in the context of mechanical, physical, or chemical lab testing of materials.
4. Adjudication Method for the Test Set
Not applicable. See explanation above. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex medical imaging or clinical outcomes by multiple human readers, not for standardized material property testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study assesses the interpretive performance of human readers, sometimes with and without AI assistance, typically in diagnostic imaging. It is not relevant for a material science device like Aidite Pmma.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a material, not a software algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- International Standards: Adherence to specific parameters and methodologies defined in standards such as ISO 10477 (Dentistry-Polymer-based crown and bridge materials), ISO 7491 (Dental materials-Determination of color stability), ISO 10993 series (Biological evaluation of medical devices), and ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages).
- Predicate Device Equivalence: Demonstrating that its characteristics and performance are "substantially equivalent" to a legally marketed predicate device (K141421), implying that the predicate's established safety and effectiveness serve as a benchmark.
8. The Sample Size for the Training Set
Not applicable. This is a physical dental material, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is relevant for this device.
§ 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.