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K Number
K051006
Device Name
IBOND NEXT GENERATION
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2005-06-07

(48 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
  • Bonding of direct composite restorations (including Polyglas® and Compomer)
  • Bonding of direct composite restoration with a light-curing luting cement:
  • Bonding of indirect restoration in combination with a light-curing luting cement: Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns).
  • Sealing hypersensitive areas of teeth.
Device Description

Not Found

AI/ML Overview

The input document does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding clearance for their "iBond™ Next Generation" resin tooth bonding agent. It outlines the regulatory classification, general controls, and indications for use of the device.

Therefore, I cannot extract the requested information from 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.