(150 days)
Ti-Core® Flow+ is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure), as a base prior to fabricating an indirect restoration, and as a post cement. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.
Ti-Core® Flow+ is a dual-cure resin cement that can be used as a luting agent and core material. It is packaged in the familiar double-barrel syringe and our materials with the puttless other dental materials. The steps required to oroperly express the cement are: remove cap, attach mixer, attach dispensing tip, press plunger. After use, the mixer/dispensing tip should be discarded and the cap replaced.
The contents of the kit are
2 - Dual chambered syringes each containing 9 am resin cement
- 20 Mixers
10 - Thin dispensing tips
10 - Thick dispensing tips
The provided document describes the acceptance criteria and the study conducted for the Ti-Core® Flow+ dental resin cement.
Acceptance Criteria and Device Performance
| Acceptance Criteria (ISO Standard 4049) | Reported Device Performance (Ti-Core® Flow+) | Details |
|---|---|---|
| Film thickness | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Working and setting time | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Sensitivity to ambient light | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Depth of cure | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Flexural strength | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Water solubility and sorption | Meets or exceeds ISO specification | Non-clinical performance testing conducted. |
| Radiopacity | Does not meet due to "not claimed" | The device's radiopacity is not claimed and thus does not meet the specification, but this is presented as acceptable. |
Study Information
-
Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the traditional sense for a clinical study. The performance evaluation was based on non-clinical tests conducted according to ISO standard 4049. The sample size for these non-clinical tests (e.g., number of specimens for film thickness, flexural strength) is not provided. The provenance of these non-clinical test materials (e.g., origin of the raw materials, specific lab where tests were conducted) is also not explicitly stated, though it's implied the testing was done by Essential Dental Systems or a contracted lab. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical, in-vitro study based on ISO standard specifications, not a study requiring expert clinical ground truth assessment on human data. -
Adjudication method for the test set:
Not applicable. This was a non-clinical, in-vitro study. -
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 document pertains to a dental resin cement, not an AI-powered diagnostic device, and no human reader studies are described. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device. -
The type of ground truth used:
The "ground truth" for evaluating the device's performance against its acceptance criteria was the ISO standard 4049 specification limits for various physical and chemical properties of dental resin cements. -
The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set. -
How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
§ 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.