(23 days)
Indermil™ Dental is indicated for use as a dental cement for bonding dental materials, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
Indermil™ Dental is liguid n-butvl 2-cyanoacrylate that cures in the presence of anions. Indermil™ Dental is sterilized by gamma radiation, and provided for use in high density polyethylene dispensers.
The provided text describes a medical device, Indermil™ Dental, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in your prompt regarding device validation or clinical trials.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results or performance metrics as you might find for a novel device or a device requiring de novo classification.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided input. The document explicitly states: "test results further demonstrate that the two devices are equivalent in performance." This implies studies were done to compare Indermil™ Dental to its predicates, but the details of those studies (e.g., specific metrics, sample sizes, ground truth) are not included in this summary.
§ 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.