IBOND GLUMA INSIDE

• K Number: K022612
• Device Name: IBOND GLUMA INSIDE
• Manufacturer: HERAEUS KULZER, INC.
• Date Cleared: 2002-10-28 ( 83 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: K041960

Intended Use

Bonding composite, comporner and Polyglas® resins to the tooth structure as well for indirect restorations (e.g. Anglass®, procelain) and sealing of prepared teeth prior to amalgam placement.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the limited information provided in the document, I cannot fulfill your request. The document is an FDA 510(k) clearance letter for a dental bonding agent (iBond™ Gluma® inside). It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.

However, the document does not contain any information about acceptance criteria, device performance data, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment as these details are typically found in the 510(k) submission itself, not the clearance letter.

Therefore, I cannot generate the table or answer the specific questions about the study and performance metrics.

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.