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K Number
K982259
Device Name
CHROMA ZONE COLOR STAIN
Manufacturer
KURARAY AMERICA, INC.
Date Cleared
1998-09-22

(88 days)

Product Code
EBF,DAT
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K943169,K933030,K871635,K925383,K965091,K974486,K943168,K855211,K811669,K801732,K962878,K955331,K954115,K972292,K964578,K940800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Color characterization for:

    1. Jacket crown
  • Facing crown 2)
    1. Inlay and onlay
Device Description

CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
CHROMA ZONE COLOR STAIN consists of 11 Stain Pastes, the Clear Paste and accessories. These components are similar to that of stain materials of the products in the paragraph 4 of this summary.
In general, resin-based crown and bridge materials consists of body resin such as transparent, enamel and dentin, opaque resin, stain and accessories. CHROMA ZONE COLOR STAIN is a stain material for color characterization to be used in conjunction with resin-based crown and bridge materials.

AI/ML Overview

This document is a 510(k) premarket notification for the "CHROMA ZONE COLOR STAIN" device. It does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria through metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The safety is primarily assessed through biological evaluation (acute toxicity and genotoxicity tests) of key components.

Here's an breakdown of the information presented:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain specific acceptance criteria for performance metrics (e.g., color accuracy, color stability over time, wear resistance) typically associated with a "performance study" in the context of device efficacy.

The "performance" described is largely about the chemical stability and biological safety of its components, and its equivalence to predicate devices in function and intended use.

The biological evaluation section provides the following performance data:

TestComponentAnimalDosing RouteAcceptance CriteriaReported Performance
Acute ToxicityBGPMouseOral(Not explicitly stated, but implied to be non-toxic at high doses)LD50: not less than 8,000 mg/kg
Acute ToxicityDTARatOral(Not explicitly stated, but implied to be non-toxic at high doses)LD50: not less than 3,000 mg/kg (I.P. greater than 2,000 mg/kg)
Genotoxicity TestDTAN/AN/A(Not explicitly stated, but implied to be non-mutagenic)Negative (Ames test)

2. Sample Size Used for the Test Set and Data Provenance:

  • Acute Toxicity (BGP): Animal: Mouse. Specific sample size (number of mice) is not provided.
  • Acute Toxicity (DTA): Animal: Rat. Specific sample size (number of rats) is not provided.
  • Genotoxicity Test (DTA): Method: Ames test. This is an in vitro bacterial test; a "sample size" in the conventional sense of human or animal subjects is not applicable here.

The data provenance is from laboratory testing (in vivo animal studies for toxicity and in vitro bacterial tests for genotoxicity). The country of origin for these specific tests is not explicitly stated, but the submitter is a Japanese company (Kuraray Co., Ltd.). This is prospective testing conducted to support the device's safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

  • This information is not applicable to the data presented. The "ground truth" for toxicity and genotoxicity tests is established by standardized laboratory protocols and scientific interpretation of results, not by expert consensus in the same way clinical diagnostic studies use experts.

4. Adjudication Method for the Test Set:

  • This is not applicable as the document describes laboratory safety testing, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

  • No, an MRMC comparative effectiveness study was not done. This document describes a dental material (a color stain for dental restorations), not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI" is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

  • No, a standalone performance study was not done. Again, this is a material device, not an algorithm.

7. The Type of Ground Truth Used:

  • For the biological evaluation, the "ground truth" is based on standardized toxicological endpoints (LD50 values for acute toxicity, and negative/positive results for genotoxicity) as determined by established laboratory testing methods. There is no external "ground truth" like pathology or outcomes data in the context of a clinical study for these tests.

8. The Sample Size for the Training Set:

  • This is not applicable. This device is a material, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

  • This is not applicable for the same reason as above.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.