(169 days)
Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications
- Long-term temporary restorations (up to 6 months),
- Teeth for removable dentures
dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.
The provided text is a 510(k) summary for the medical device "dima Print Teeth & Temp". It outlines the general regulatory information, device description, and indications for use. However, it does not contain the detailed information about acceptance criteria, device performance results, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies that would be expected for a comprehensive study proving the device meets acceptance criteria.
The document states:
"Testing of the physical characteristics as listed in the predicate comparison table was conducted to evaluate the performance of dima Print Teeth & Temp, according to requirements of ISO 10477 and ISO 22112. All requirements were met."
This statement confirms that testing was done and requirements were met, but it does not provide the specific details of the acceptance criteria or the reported performance values. It also explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)", indicating that a clinical study of the type described in questions 5, 6, and 7 was not performed or not required for this 510(k) submission.
Therefore, based solely on the provided text, I cannot provide a detailed answer to all parts of your request. I will indicate where the information is not present.
Acceptance Criteria and Device Performance Study for dima Print Teeth & Temp
Based on the provided FDA 510(k) summary (K233868), the device "dima Print Teeth & Temp" was evaluated against performance requirements derived from ISO 10477 and ISO 22112. The summary confirms that "All requirements were met." However, the specific acceptance criteria and the reported numeric performance values are not detailed in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from ISO 10477/22112) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Not explicitly detailed in document | All requirements met |
| ISO 10477 conformance | e.g., Flexural Strength, Water Sorption, etc. (specific values from standard) | Met ISO 10477 requirements |
| ISO 22112 conformance | e.g., Color stability, Surface roughness, etc. (specific values from standard) | Met ISO 22112 requirements |
Note: The document states that testing was "according to requirements of ISO 10477 and ISO 22112" and that "All requirements were met." However, the specific quantitative acceptance criteria (e.g., "flexural strength > Y MPa") and the measured device performance (e.g., "flexural strength = Z MPa") are not provided in this 510(k) summary. These details would typically be in the full submission documentation.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary. These physical/material tests are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information is generally relevant for studies involving human interpretation (e.g., imaging devices) where expert consensus is needed for ground truth. For physical material properties testing (as indicated by the reference to ISO 10477 and ISO 22112), ground truth is established by standardized test methodologies and measurements, not by expert consensus on human data. Therefore, this question is not applicable in the context of the reported non-clinical testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human readers provide subjective assessments that need to be reconciled for ground truth. This was a non-clinical, physical properties test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This indicates that a clinical study, including an MRMC study comparing human readers with and without AI assistance, was not performed or not required for this 510(k) submission for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The device is a "photopolymer liquid for 3D printing of dental appliances," not an AI algorithm. Therefore, a standalone algorithm performance evaluation is not relevant. The device itself is the material.
7. The Type of Ground Truth Used
For the performance testing reported (physical characteristics according to ISO 10477 and ISO 22112), the ground truth is established by standardized laboratory testing procedures and direct physical measurements as defined by the referenced ISO standards. This is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The device is a material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.