EXCEL BOND DC, MODEL 28-200100

• K Number: K060882
• Device Name: EXCEL BOND DC, MODEL 28-200100
• Manufacturer: J. MORITA USA, INC.
• Date Cleared: 2006-09-01 ( 154 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Excel Bond LC is intended to be used as a Self Etching Dental Adhesive.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental bonding agent called "Excel Bond LC" (K060882). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI or imaging device.

The letter is focused on determining substantial equivalence of this dental adhesive to a legally marketed predicate device, as required for traditional medical devices, not AI/ML-enabled devices.

Therefore, I cannot provide the requested information based on the input text.

Regulation Number and Section

§ 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.