(84 days)
TempoCem is a dental luting agent indicated for:
- . temporary cementation of provisional crowns and bridges
- cementing of semi-permanent implants .
TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.
The provided text describes a 510(k) premarket notification for a dental temporary cement called TempoCem. The information focuses on regulatory approval based on substantial equivalence to predicate devices and adherence to an international standard.
Based on the provided text, the following information regarding acceptance criteria and a study proving the device meets these criteria can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for TempoCem, as stated, is that it "meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." The text does not provide a table with specific numerical acceptance criteria from this ISO standard nor specific reported performance values for TempoCem against these criteria.
| Acceptance Criteria (from ISO Equivalenoo [likely ISO 3107: Dental zinc oxide/eugenol and zinc oxide/non-eugenol cements - Third Edition]) | Reported Device Performance (TempoCem) |
|---|---|
| Specific requirements of ISO 3107 for dental cements (e.g., film thickness, compressive strength, setting time, solubility, adhesion, etc. - not detailed in current document) | "Meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." |
| "Low film thickness provides an exceptional fit." | |
| "Combines reliable adhesion with easy and clean removal." | |
| (Specific numerical performance values are not provided in this document). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that the submission is an "Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This typically means that new clinical data or extensive performance data might not be required if the device is substantially equivalent to a legally marketed predicate and adheres to recognized standards.
- Sample Size for Test Set: Not specified. The document implies compliance with an ISO standard rather than a specific clinical trial with a defined test set sample size.
- Data Provenance: Not specified. The compliance is with an "ISO" standard, which is an international standard, but the location where the tests were conducted or the origin of any data (if external to the standard's methodology) is not mentioned. It is highly likely the data is from in vitro laboratory testing to demonstrate compliance with the standard. The study is not a retrospective or prospective clinical study in the traditional sense described in the context of device performance in humans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. The device's substantial equivalence is based on meeting an ISO standard for dental cements and comparison to predicate devices, not on expert-adjudicated ground truth from a test set of patient data.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As above, the evaluation is based on compliance with an ISO standard, not a human reader or expert adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. The approval is for a dental cement, not an imaging or diagnostic device that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This concept is not applicable to this device. TempoCem is a physical dental cement, not an algorithm or AI system. Its performance is intrinsic to the material properties.
7. Type of Ground Truth Used:
The "ground truth" here is compliance with an international standard (ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition). This standard likely sets forth methodologies and acceptable ranges for various physical and chemical properties of dental cements.
8. Sample Size for the Training Set:
This information is not applicable and not provided. As TempoCem is a manufactured product and not an AI/ML algorithm, there is no "training set" in the context of data science or machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. There is no ground truth for a training set in this context.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.