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K Number
K991711
Device Name
BISTITE II SC
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1999-07-07

(49 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K933030,K855211,K960464
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.

Device Description

The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.

AI/ML Overview

The provided text is a 510(k) summary for a dental cement called Bistite II SC. It outlines the product's intended use, substantial equivalence to other marketed devices, and regulatory approval. However, it does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would demonstrate the device meets such criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document primarily focuses on:

  • Product Identification: Bistite II SC, a self-curing dental cement.
  • Intended Use: Cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges, and CR core posts.
  • Regulatory Status: Substantially equivalent to previously marketed dental cement products (Panavia 21, Panavia EX, C&B Metabond).
  • Contraindications and Warnings: Hypersensitivity to methacrylate monomers, avoid contact with skin/eyes.
  • Regulatory Approval: Received approval from the Japanese Government and FDA 510(k) clearance.

§ 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.