Search Results

It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.

DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements.

This K122549 510(k) summary describes a dental device called DentoTemp. The submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents and international standards. This type of submission is typically used for devices that are well-understood and for which performance standards and test methods are well-established.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for DentoTemp are directly aligned with its technological characteristics and intended uses, compared against a predicate device (Premier Implant Cement K033309) and relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

2. Rebasing of crowns;
3. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. | 1. Quick temporary cementation of temporary crowns and bridges;
4. Rebasing of crowns;
5. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. |
   | Working time (sec) | Approximately 90s | 90-120s |
   | Solubility (µg/mm³) | Low | Low |
   | Setting time at 37 °C (min) | Approximately 4-5 min | 2.5-3 min |
   | Film thickness (µg/mm³) | 15 µg/mm³ | 15 µg/mm³ |
   | Shelf life (Years) | 2 years | 2 years |
   | Linear Shrinkage (%) | 2.5% | 2.5% |

Note on "Acceptance Criteria" for Functional Properties: The document implies that meeting or improving upon the predicate device's performance, as well as conforming to relevant standards (ISO 4049 and FDA guidance), constitutes the acceptance criteria. For quantitative metrics like working time, setting time, film thickness, and linear shrinkage, the values of the predicate device serve as benchmarks. For qualities like "low solubility," the standard or common understanding within the industry for temporary dental cements determines acceptance.

Study Information

The provided document describes an Abbreviated 510(k) submission. This means that extensive, novel clinical trials demonstrating effectiveness may not have been performed in the same way as for a completely new technology. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Premier Implant Cement, K033309) by adhering to established performance standards and guidance documents.

Here's what can be inferred or directly stated about the "study" based on the provided information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not provide details on specific sample sizes for particular tests. As an Abbreviated 510(k), it relies on conformity with established standards (ISO 4049) and FDA guidance for dental cements. These standards dictate specific test methods and often include requirements for sample sizes, but these are not explicitly presented here as "test set" samples for a novel study.
   • The data provenance is not specified beyond "Itena Clinical has provided information to demonstrate conformity." It's likely these tests were performed in a lab setting to ISO standards, but the location is not further detailed. The submission came from France.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This question is not applicable in the context of this submission. The "ground truth" for the performance characteristics of a dental cement like DentoTemp is established by universally recognized physical and chemical testing methods outlined in standards such as ISO 4049, not by expert consensus on clinical cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes where an expert panel provides a gold standard. For material property testing of a dental cement, the "adjudication" is inherent in the standardized test methods and measurement protocols.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic AI devices, particularly in medical imaging. DentoTemp is a dental cement, a material device, and does not involve AI or human interpretation in this manner.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. This question pertains to AI/algorithm performance. DentoTemp is a material device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance characteristics (e.g., working time, setting time, film thickness, solubility, linear shrinkage, shelf life) is established through standardized laboratory testing methods as specified in ISO 4049 and likely FDA guidance documents for dental cements. The results of these tests (e.g., a measured working time of 90-120 seconds) directly represent the "truth" of the material's properties under specified conditions.

7. The sample size for the training set:

   • This is not applicable. "Training set" refers to data used to train machine learning models. As DentoTemp is a material device, there is no AI or machine learning involved, and thus no training set in this context.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reasons as #7.

In summary, the "study" for K122549 is a non-clinical performance evaluation demonstrating that DentoTemp's physical and chemical properties conform to recognized industry standards (ISO 4049) and FDA guidance for dental cements, and that these properties are substantially equivalent to those of the predicate device. This approach is standard for Abbreviated 510(k) submissions for well-understood material devices like dental cements.

Ask a specific question about this device