(55 days)
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
This exemption refers to a 510(k) premarket notification for a dental cement product. For such submissions, the acceptance criteria are generally established through a comparison to a legally marketed predicate device, demonstrating substantial equivalence rather than through a standalone study with specific performance metrics and acceptance criteria.
Therefore, the provided documents do not contain the typical information one would find for a study that proves a device meets specific, quantitative acceptance criteria through a clinical or performance study with statistical endpoints. Instead, the "study" demonstrating performance is the comparison to a predicate device, supported by laboratory testing to ensure physical and chemical properties are comparable and safe.
Here's an analysis based on the provided text, outlining what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document focuses on substantial equivalence rather than meeting specific quantitative acceptance criteria like those found in a clinical trial. The "acceptance criteria" here are implicitly that the new device performs "the same intended function" and has similar "safety and effectiveness" as the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Intended function for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. | Performs the same intended function as its predicate device, MaxCem (K041474). |
| Not recommended for use on veneer restorations. | Not recommended for use on veneer restorations. |
| Dual cure luting agent. | Is a dual cure luting agent. |
| Self-etch adhesive resin cement. | Is a self-etch adhesive resin cement. |
| Does not require etchant, primer, or adhesive. | Due to self-etching and adhering properties, does not require the use of an etchant, primer, or adhesive. |
| Filler content, particle size, and type. | Approximately 65% filler by weight with particle sizes |
§ 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.