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K Number
K990699
Device Name
ORTHO-GLOW GLITTER
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-05-17

(75 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Decorative additive for acrylic resin systems to add glitter and/or metallic appearance and/or artistic shapes/designs to orthodontic retainers, and other orthodontic appliances and to dentures, splints, and mouth guards.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter from the FDA to the Harry J. Bosworth Company for a device called "Ortho-Glow Glitter."

The letter states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

The document does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about a test set, its sample size, or data provenance.
  • Information about experts used to establish ground truth or their qualifications.
  • Adjudication methods.
  • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Results from a standalone algorithm-only performance study.
  • The type of ground truth used.
  • The sample size for the training set or how its ground truth was established.

The "INDICATIONS FOR USE" section describes the intended purpose of the product as a "Decorative additive for acrylic resin systems to add glitter and/or metallic appearance and/or artistic shapes/designs to orthodontic retainers, and other orthodontic appliances and to dentures, splints, and mouth guards." This suggests that the device's primary function is decorative, and the FDA's substantial equivalence determination for such a product typically focuses on material safety and compatibility, rather than complex performance metrics that would require the kinds of detailed studies you've asked about.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.