LogoFDA 510(k) Search
K Number
K051050
Device Name
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
Manufacturer
SCHUTZ-DENTAL GMBH
Date Cleared
2005-06-29

(65 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

Sebond Pink: Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary)
Sebond Smart: Odorless metal primer, universally suitable for all metals, guarantees a lasting bond.
Sebond Grip: Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

§ 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.