(259 days)
FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.
The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.
FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.
The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.
The provided text is a 510(k) summary for a dental device called "FixTemp C&B". This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.
Therefore, many of the requested elements for an AI/software device are not applicable to this submission. This is a traditional medical device submission, not a software as a medical device (SaMD) submission.
Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable:
Acceptance Criteria and Device Performance for FixTemp C&B
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from ISO 10993/ASTM Standards where stated) | Reported Device Performance (FixTemp C&B) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Not cytotoxic (based on Agar Diffusion Test, Din EN ISO 10993-5, using L929 mouse fibroblasts). | Met criteria of the test and was found to be non-cytotoxic. |
| Sensitization | Did not induce sensitization (based on modified Guinea Pig Maximization Test (GMPT), ASTM F720-81). | Did not induce any sensitization. |
| Genotoxicity | Non-mutagenic (based on Ames test, with or without metabolic activation). | Fixtemp C&B (extract) was non mutagenic in the Ames test either with or without metabolic activation. |
| Carcinogenicity | Not required if negative genotoxicity/cytotoxicity and low exposure. | Not conducted as not thought necessary due to extraordinarily low exposure levels and negative genotoxicity and cytotoxicity tests, conforming to general plastics testing procedures. |
| Implantation | Not required if contact only with hard/surface soft tissues (DIN EN ISO 10993). | Not conducted as material only comes into contact with oral hard tissues and the surface of oral soft tissues when used as prescribed. |
| Acute Systemic Toxicity | Not explicitly obligatory per DIN EN ISO 10993; components with >3% content have low acute oral toxicity and are generally used in dental materials. | Not specifically evaluated. Components with >3% have very low acute oral toxicity and are approved for use in dental materials by FDA. |
| Inhalation Toxicity | Not required if practically no volatile compounds and not used as aerosol (FDA G95-1 memo). | Not thought useful and not conducted as it contains practically no volatile compounds and is not used as an aerosol. |
| Functional/Other | ||
| Radiopacity | (Implicitly, to allow easy radiographic identification) | Contains methacrylate components and is radiopaque for easy radiographic identification. |
| Suitability for Use | Form suitable structure for short and long-term crown and bridge temporaries. | Provides a dental material to short and long term dental provisional prosthetics. |
| Compatibility | Compatible with light cured composites for repair and characterization. | Compatible with light cured composites for repair and characterization. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For biocompatibility tests, sample sizes are typically standardized by the test methods (e.g., number of cell cultures, animals) but specific numbers are not given here.
- Data Provenance: Not explicitly stated but implied to be from laboratory bench testing. No mention of country of origin or whether clinical (retrospective/prospective) data was used, as this is a material science device, not a data-driven AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a material testing submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI systems, not for biocompatibility testing of dental materials. Biocompatibility results are based on objective laboratory measurements and biological responses defined by standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, particularly in AI performance validation. This is not relevant to chemical and biological material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study is designed to evaluate human reader performance, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a dental material (Crown & Bridge Temporary resin).
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. There is no algorithm or software component described that would require a standalone performance study.
7. Type of Ground Truth Used
- Laboratory Test Results / Standardized Biological Responses: The "ground truth" for the device's performance is established by the results of standardized biological and chemical tests (e.g., cytotoxicity assays, sensitization tests, genotoxicity assays) performed according to international standards (e.g., ISO 10993 parts, ASTM F720-81). These tests provide objective measures of the material's interaction with biological systems.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is a medical device clearance based on material properties and substantial equivalence, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See 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.