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K Number
K980539
Device Name
SOLOBOND M
Manufacturer
VOCO GMBH
Date Cleared
1998-03-23

(39 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K994056
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Solobond M is intended for use as an adhesive bond between hard dental tissue (dentin / enamel) and light-curing restorative materials.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "Solobond M." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval, not a scientific study report. It indicates that the manufacturer submitted data to demonstrate substantial equivalence, but the details of those studies are not present in this document.

Therefore, I cannot fulfill your request for the specific information you asked for based on the provided text.

§ 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.