(105 days)
Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.
The provided document is a 510(k) premarket notification for a medical device called "Life Regular Set and Life Fast Set," which are calcium hydroxide cavity liners and pulp capping agents. It seeks to demonstrate substantial equivalence to a predicate device, "Life 2 (K012717)."
The document does not include the detailed information requested regarding specific acceptance criteria for device performance (e.g., accuracy metrics, thresholds), a study comparing the device against these criteria, or information on human reader studies, ground truth establishment with experts, or training set details for an AI/CAD system.
Instead, the document focuses on demonstrating substantial equivalence based on:
- Similarity in intended use and technological characteristics: The new device has the same intended use and a very similar formulation to the predicate. The primary difference in formulation is a change in the type of fumed silica, which is stated to be insignificant as it does not participate in the reaction.
- Manufacturing and packaging changes: The manufacturing location has changed, and the packaging material has been updated. These changes were validated internally.
- Non-clinical performance data: Verification and validation activities were performed according to design control requirements (21 CFR 820.30 and ISO 13485:2012) and risk analysis (ISO 14971:2012). The conclusion states these activities demonstrated substantial equivalence and that no new hazards were identified based on post-market data from the internationally sold product.
Therefore, I cannot provide the requested table or detailed information because the provided text does not describe a study that establishes acceptance criteria in terms of quantitative reported device performance for an AI/CAD system, nor does it detail a study proving the device meets distinct performance thresholds. The document's purpose is to demonstrate substantial equivalence to an existing device based on material, manufacturing, and packaging changes, supported by non-clinical validation and risk analysis, rather than a clinical performance study with specific metrics.
If this were an AI/CAD device, the requested information would be crucial. However, for this type of dental material, the FDA's review focuses more on the safety and efficacy of the formulation and manufacturing process, and its equivalence to a device already on the market.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.