(170 days)
Interlig is indicated for:
- Splinting periodontal involved and mobile teeth to prevent movement
- To reinforce full denture and partial denture repairs
- As a matrix between abutment teeth for receiving a temporary replacement tooth
- As an aid in the reinforcement of temporary crowns and bridge work
- As a space maintainer for orthodontic involved teeth
Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.
The provided document K123823 is a 510(k) summary for a dental device called "Interlig," a glass fiber reinforcement material. The document primarily focuses on establishing substantial equivalence to a predicate device ("Splint It" K972985) and does not contain information on detailed acceptance criteria or a specific study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
The document states:
- "Interlig has the same intended use and similar technical characteristics as Splint It K972985. The indications for use, materials, form factor, performance and safety characteristics between Interlig and Splint It are the same."
- "Based on the information provided in this premarket notification, we can conclude that Interlig is as safe and effective as the predicated device."
This 510(k) submission relies on demonstrating similarity to a previously cleared device rather than presenting a de novo performance study with specific acceptance criteria and results for the new device. Therefore, I cannot provide the requested information.
However, based on the type of document, I can infer what would typically be presented for such a submission if a new performance study were conducted. Since it is not present in the given text, I will state explicitly that the following is not found in the document.
Information NOT Found in the Provided Document:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set and data provenance.
- Number of experts used to establish ground truth for a test set and their qualifications.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
The provided 510(k) summary for K123823 does not contain the detailed performance study information requested. It establishes substantial equivalence to a predicate device (Splint It K972985) based on similar intended use, technical characteristics, indications for use, materials, form factor, performance, and safety characteristics. No specific performance metrics, acceptance criteria, or study results proving such criteria directly for the Interlig device are presented in this document.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.