FINAL VARNISH LC

• K Number: K030844
• Device Name: FINAL VARNISH LC
• Manufacturer: VOCO GMBH
• Date Cleared: 2003-06-13 ( 88 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Protection of glass ionomer cement surfaces against both humidity and drying immediately after placing the filling

Sealing and smoothing of glass ionomer cement surfaces after polishing

Sealing of cervical margin of cementations immediately after removal of excess

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental device called "Final Varnish LC." It contains information about the regulatory classification, indications for use, and general compliance requirements.

However, this document does not contain any information regarding:

• Acceptance criteria for performance.
• Details of a study that proves the device meets specific criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Information on experts, ground truth establishment, or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided 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.