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K Number
K980990
Device Name
POLYCARBOXYLATE CEMENT
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-07-31

(136 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.

Device Description

Polycarboxylate Cement

AI/ML Overview

This is a 510(k) clearance letter for a Polycarboxylate Cement. 510(k) submissions for devices like this, which are physical materials used in dentistry, typically do not involve the kind of performance studies with acceptance criteria, human experts, and ground truth detailed in your request. Such studies are more common for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the information requested from the provided text for the following reasons:

  • Type of Device: Polycarboxylate Cement is a dental restorative material, not an AI-powered diagnostic or predictive device. Its clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, primarily through material properties, biocompatibility, and intended use, rather than clinical performance metrics against a "ground truth" derived from expert interpretation.
  • Lack of Clinical Study Details: The provided document is a clearance letter, not a summary of a clinical study or a detailed technical submission. It states that the device is "substantially equivalent" to predicate devices. This equivalence is typically demonstrated through bench testing and comparisons of characteristics, not through studies involving human readers or complex ground truth adjudication.

In summary, there is no information in the provided text to complete the requested table and answer the specific questions about acceptance criteria, clinical study design, expert involvement, or AI/ML performance metrics.

§ 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.