(22 days)
Not Found
No
The summary describes a simple acrylic varnish and its drying time testing, with no mention of AI or ML technologies.
No.
The device is an acrylic varnish used for sealing surfaces of dental prosthetics and temporary crowns/bridges, indicating a functional rather than a therapeutic purpose.
No
Explanation: The device, Hydro-Cast Acrylic Varnish, is described as being applied to cured materials like dentures to seal the acrylic surface. Its intended use and device description focus on material properties and application, not on identifying, detecting, or measuring a medical condition or disease. The performance studies also focus on product drying time, not diagnostic capabilities.
No
The device is a physical substance (acrylic varnish) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to seal the surface of cured dental materials like dentures and splints. This is a physical application to a device, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description lists chemical components used to form a varnish. This aligns with a material applied to a surface, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Use in a laboratory or clinical setting for testing purposes
The testing described focuses on the physical property of drying time, which is relevant to the application of a surface coating, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Is applied to cured materials such as dentures, partial dentures, dental splints, and temporary crowns/bridges for the purpose of sealing the acrylic surface.
Product codes
EIA
Device Description
Acrylic varnish.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The testing of Hydro-Cast Acrylic Varnish was conducted using five randomly drawn subgroups, with three samples taken from each subgroup. The samples were applied to acrylic denture surfaces and the drying time observed. The specification for drying time is, dry to the touch in
§ 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.
0
4/29/99
Image /page/0/Picture/1 description: The image shows the words "510K SUMMARY" in large, bold letters at the top. Below that, there is a handwritten number "K991161". The text and number are centered on a white background.
1
Date Prepared 04/06/99
Submitted by Clark Smith D.M.D.
Kay-See Dental 124 East Missouri Avenue Kansas City, MO 64106
Telephone 800-842-8844 Fax 816-842-3204 :
Contact Clark Smith D.M.D.
Prepared by Barry Hale 7707 E 201 terr Belton, MO 64012 816-322-4641
2
Trade name - Hydro-Cast Acrylic Varnish
Common name - Acrylic Varnish
Classification Name - Resin, Denture, Relining, Repairing, Rebasing (872.3760)
Substantial equivalence claimed to - PalaSeal K892452
Description of the device. Acrylic varnish.
Intended use of device Is applied to cured materials such as dentures, partial dentures, dental splints, and temporary crowns/bridges for the purpose of sealing the acrylic surface.
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TECHNOLOGICAL CHARACTERISIC COMPARISON
PalaSeal
Preparation of methyl methacrylate monomer, multifunctional methacrylates, light sensitizer, polymerization initiator.
Hydro-Cast Acrylic Varnish
Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.
Summary: The technological characteristics of the two devices are identical.
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NON-CLINICAL TESTING AND DATA
The testing of Hydro-Cast Acrylic Varnish was conducted using five randomly drawn subgroups, with three samples taken from each subgroup. The samples were applied to acrylic denture surfaces and the drying time observed. The specification for drying time is, dry to the touch in