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510(k) Data Aggregation
(184 days)
Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.
Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.
Acceptance Criteria and Device Performance for Fixtemp® C&B
The Fixtemp® C&B device is a resin-based material used to fabricate temporary crowns and bridges. Its performance was evaluated against a set of non-clinical criteria to establish substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (or Reference Standard) | Reported Device Performance |
|---|---|---|
| Working / Processing time | ≥ 45 sec | ≥ 45 sec |
| Curing time in mouth (flexible phase) | ≥ 2 - 3 min | ≥ 2 - 3 min |
| Setting time | ≥ 6 min | ≥ 6 min |
| Hardness (1h) | ≥ 75 Shore D | ≥ 75 Shore D |
| Hardness (24h) | ≥ 80 Shore D | ≥ 80 Shore D |
| Compressive strength | ≥ 200 MPa (according to DIN EN ISO 4049:2010) | ≥ 200 MPa (according to DIN EN ISO 4049:2010) |
| Flexural strength | ≥ 60 MPa (according to DIN EN ISO 4049:2010) | ≥ 60 MPa (according to DIN EN ISO 4049:2010) |
| E-modulus | > 1500 (according to DIN EN ISO 4049:2010) | > 1500 (according to DIN EN ISO 4049:2010) |
| Water absorption | Pass (according to DIN EN ISO 4049:2010) | Pass (according to DIN EN ISO 4049:2010) |
| Radiopacity | ≥ 1.00 mm aluminium/mm material (according to DIN EN ISO 4049:2010) | ≥ 1.00 mm aluminium/mm material (according to DIN EN ISO 4049:2010) |
| Cytotoxicity | No biological reactivity (Grade 0) based on ISO 10993-5 | No biological reactivity (grade 0) of the cells exposed to the test article. (Test report: "Toxikon Europe Final GLP Report: 17-01389-G1") |
| Carcinogenic potential | No evidence for causing cancer within the time period of use (up to 29 days) | Different evaluations and assessments have been made for cured Fixtemp® C&B and they have shown that there is no evidence for causing cancer within the time period of use in the patients mouth for up to 29 days. |
| Mutagenic potential | No evidence for mutagenic reactions within the time period of use (up to 29 days) | Different evaluations and assessments have been made for cured Fixtemp® C&B and they have shown that there is no evidence for mutagenic reactions within the time period of use in the patients mouth for up to 29 days. |
| Irritating potential | No evidence for irritation within the time period of use (up to 29 days) | Different evaluations and assessments have been made for cured Fixtemp® C&B and they have shown that there is no evidence for irritation within the time period of use in the patients mouth for up to 29 days. |
| Sensitizing potential | No evidence for sensitization within the time period of use (up to 29 days) | Different evaluations and assessments have been made for cured Fixtemp® C&B and they have shown that there is no evidence for sensitization within the time period of use in the patients mouth for up to 29 days. |
| Shelf life | 2 years | The results of stability tests at 23 °C/37 °C justify to assume a shelf life of 2 years for Fixtemp® C&B. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of specimens for compressive strength). It generally refers to "a series of in-house tests" and adherence to specific ISO standards (e.g., DIN EN ISO 4049:2010).
For the cytotoxicity testing, the test was conducted by the independent laboratory Toxikon Europe. The provenance of the data is indicated as "Toxikon Europe Final GLP Report: 17-01389-G1". The country of origin for the manufacturing company (Dreve Dentamid GmbH) is Germany. It is implied that these are prospective tests performed on the Fixtemp® C&B material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance evaluation relies on standardized tests (e.g., ISO standards) and laboratory findings rather than expert consensus on a test set in the typical sense of diagnostic imaging or clinical studies. The cytotoxicity test was conducted by an "independent laboratory," but the qualifications of the individuals establishing the ground truth (i.e., interpreting the cytotoxicity results) are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The reported tests are objective measurements based on standardized procedures and laboratory analysis, not subjective interpretations requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. Fixtemp® C&B is a material for fabricating dental prosthetics, and its performance is evaluated through material properties and biocompatibility, not reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. Fixtemp® C&B is a dental material, not an algorithm or software. Its performance is inherent to its physical and chemical properties.
7. The Type of Ground Truth Used
The ground truth for the performance tests consists of:
- Standardized measurement directly from testing: This applies to properties like working time, curing time, setting time, hardness, compressive strength, flexural strength, E-modulus, water absorption, and radiopacity, where the "ground truth" is a measured physical or chemical property that meets or exceeds a predefined numerical threshold from an established standard (e.g., DIN EN ISO 4049:2010).
- Laboratory findings: For cytotoxicity, the ground truth is established by the results of the ISO 10993-5 test conducted by an independent laboratory, indicating the absence of biological reactivity.
- Evaluations and assessments: For carcinogenic, mutagenic, and irritating/sensitizing potentials, the ground truth is based on "different evaluations and assessments" indicating no evidence of these effects within the specified time frame. While the specifics of these evaluations are not detailed, they likely rely on established toxicological principles and potentially other in-vitro or in-vivo studies not explicitly listed.
8. The Sample Size for the Training Set
Not applicable. Fixtemp® C&B is a physical material, not an AI model or software 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.
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