HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

• K Number: K991161
• Device Name: HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
• Manufacturer: KAY SEE DENTAL MFG. CO.
• Date Cleared: 1999-04-29 ( 22 days)
• Product Code: EIA
• Regulation Number: 872.6640
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K892452

Intended Use

Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.

Device Description

Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dry to the touch in

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.