(45 days)
- Lining and basing applications under composite, amalgam, ceramic or metal restorations.
- Treatment of exposed root surface sensitivity
- Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions
GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3275) because it is a device intended to provide protection as a cavity liner/basing material as well as in treatment of exposed root surfaces hypersensitivity. GILB-2 is a site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions.
GILB-2 is a two part liquid/paste system. The liquid/paste materials are contained in the Clicker™ Dispensing System manufactured by 3M ESPE. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is similar to predicate glass ionomer dental cement devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications.
The provided text is a 510(k) summary for a dental cement device named GILB-2. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on chemical composition and performance testing. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics from any clinical or performance studies.
Therefore, I cannot provide the requested information in the format specified because the input text does not contain that level of detail.
Here's why and what can be inferred:
- Acceptance Criteria and Reported Device Performance: This information is completely absent. The document states "The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications," but no actual criteria or results are listed.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth: All of these details relate to specific performance studies, whether clinical or non-clinical, that would have been conducted to demonstrate substantial equivalence. These details are not present in the 510(k) summary provided.
In summary, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods is available in the provided document. The document focuses on regulatory classification, device description, and claiming substantial equivalence to predicate devices generally, rather than detailing the specific studies used to demonstrate that equivalence.
§ 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.