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K Number
K052699
Device Name
VERSA-LINK PORCELAIN BONDING SYSTEM
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2005-11-16

(49 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.

A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental bonding system. It does not contain any information about the acceptance criteria, study details, or performance evaluation of a device as requested in the prompt.

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

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.