One Coat 7 Universal

• K Number: K152243
• Device Name: One Coat 7 Universal
• Manufacturer: Coltene/Whaledent AG
• Date Cleared: 2015-12-09 ( 121 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

One Coat 7 Universal is indicated for:

• bonding in adhesive restoration techniques
• adhesive attachment of composite materials and compomers on enamel and dentin
• adhesive attachment of ceramic and composite restorations on enamel and dentine
• composite material on ceramic, composite material, metal and amalgam
• dentine sealing

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental resin bonding agent, "One Coat 7 Universal." This type of document declares substantial equivalence to a predicate device and does not contain information about the acceptance criteria and study data typical for software or AI/ML-driven medical devices.

Therefore, I cannot provide the requested information as the document does not describe:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study data proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance.
• Type of ground truth used.
• How ground truth was established for training data.

This letter solely confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

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.