(83 days)
For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.
The product is a self cured adhesive resin cement.
The provided text is a 510(k) summary for a dental adhesive resin cement called "Tokuyama M-Bond." This type of document is for regulatory clearance of a medical device and does not contain details about acceptance criteria or specific studies to prove performance in the way a clinical trial report would.
The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria. The information provided is insufficient to populate the requested table and study details.
Here's why and what information is available:
Why the requested information is absent:
- Nature of 510(k) Summary: A 510(k) summary (like Exhibit D) is a brief overview submitted to the FDA to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It doesn't typically include detailed clinical study protocols, results, acceptance criteria, or ground truth methodologies that would be found in a full clinical trial report or a performance study to establish specific diagnostic or therapeutic efficacy.
- Device Type: Tokuyama M-Bond is a dental adhesive resin cement. Its performance is generally assessed through in vitro (laboratory) tests measuring bond strength, setting time, solubility, and biocompatibility, as well as in vivo (clinical) observation of retention and marginal integrity over time. The concept of "acceptance criteria" and "ground truth" as applied to diagnostic algorithms is not directly applicable here.
- Focus on Substantial Equivalence: The document explicitly states, "It is substantially equivalent to various marketed dental cement products." The regulatory approval is based on this equivalence, not on specific performance metrics that would be validated in a prospective study with blinded readers, ground truth established by experts, etc., as typically done for AI/diagnostic devices.
Information that is available from the text:
- Device Name: Tokuyama M-Bond
- Intended Use: "For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses." Clinical applications include cementation of inlays, onlays, crowns, metal posts and cores.
- Predicate Devices (mentioning substantial equivalence):
- Contraindications: Hypersensitivity to methacrylate monomers. Avoid contact with skin, mucosal membrane, eyes, or clothing.
- Regulatory Class: II
- Product Code: EMA
Conclusion:
Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary, which is a regulatory submission for substantial equivalence, not a detailed performance study report. The questions about sample size, data provenance, number of experts, adjudication methods, multi-reader comparative effectiveness studies, standalone performance, types of ground truth, and training set details are not addressed in this type of filing for a dental cement.
§ 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.