(226 days)
TempoCem Clear is indicated for:
- · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays.
- · Temporary luting of temporary veneers.
- · Temporary or semipermanent luting of implant-borne dental prosthesis.
TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.
The provided document is a 510(k) summary for a dental cement called TempoCem Clear. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical efficacy trial with established benchmarks. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical performance data.
Here's an analysis based on the information provided, attempting to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" against which the device performance is measured in a pass/fail manner. Instead, it compares the performance of TempoCem Clear to a predicate device (Telio CS Link) and references relevant ISO standards and FDA guidance. The "acceptance criteria" here are implied to be "comparable to the predicate device" or "within acceptable ranges for dental cements" as defined by the mentioned standards and guidance.
| Property (unit) | Acceptance Criteria (Implied) | TempoCem Clear (proposed device) | Predicate Device (Telio CS Link) |
|---|---|---|---|
| Solubility (µg/mm³) | Comparable to predicate/within standard (ISO 7405) | 19.0 ± 1.3 | 9.1 ± 0.6 |
| Water sorption (µg/mm³) | Comparable to predicate/within standard (ISO 7405) | 65.5 ± 2.0 | 77.3 ± 1.4 |
| Dimensional change after 7 days (%) | Comparable to predicate/within standard (ISO 7405) | 1.0 ± 0.1 | 1.7 ± 0.1 |
| Gel time, self-cure (s) | Comparable to predicate/within standard (ISO 7405) | 65 | 165 |
| Setting time, self-cure (s) | Comparable to predicate/within standard (ISO 7405) | 318 | 216 |
| Bonding strength for intended use | Good to satisfactory (comparable to predicate) | Good to satisfactory | Good to satisfactory |
| Film thickness (µm) | Comparable to predicate/within standard (ISO 7405) | 6 ± 1 | 39 ± 3 |
| Heat generated during setting (peak temp, °C) | Comparable to predicate/within standard (ISO 7405) | 43.1 ± 1.3 | 43.0 ± 0.5 |
| Compressive strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 78 ± 8 | 43 ± 6 |
| Flexural strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 5.4 ± 0.3 | 6.4 ± 0.2 |
| Shear bond strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 8.7 ± 1.9 | 7.8 ± 2.0 |
| Fluoride release over 28 days (ppm) | (Unique to proposed device; predicate has no fluoride) | 8.0 ± 2.2 | No data |
| Biocompatibility | Demonstrated equivalence to predicate (cytotoxicity studies) | Equivalence demonstrated | (Predicate previously cleared) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of test specimens) for each of the physical and mechanical property tests. It states that "Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility)." This implies the tests were conducted in a laboratory setting, likely following standard test methodologies but the country of origin of the data is not specified (though the submitter information lists "DMG USA, Inc." in Massachusetts, USA). The data is by nature retrospective for the predicate device and newly generated for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. The "ground truth" for physical and mechanical properties is established by standardized laboratory measurements rather than expert human interpretation. Biocompatibility "ground truth" is established via cytotoxic assays, not expert panels.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication for these types of non-clinical, quantitative tests.
5. 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
Not applicable. This is a dental cement, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical and mechanical properties, the "ground truth" is derived from direct measurements using established laboratory test methods (e.g., measuring solubility, strength, etc.) as outlined in the FDA guidance and ISO standards (e.g., ISO Standard 7405).
For biocompatibility, the ground truth is established through cytotoxicity studies, not expert consensus or pathology in a clinical setting.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.