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:

Test	Component	Animal	Dosing Route	Acceptance Criteria	Reported Performance
Acute Toxicity	BGP	Mouse	Oral	(Not explicitly stated, but implied to be non-toxic at high doses)	LD50: not less than 8,000 mg/kg
Acute Toxicity	DTA	Rat	Oral	(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 Test	DTA	N/A	N/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.

Summary

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SEP 22 1998

Image /page/0/Picture/2 description: The image is a logo for Kuraray, a Japanese chemical company. The logo features a stylized letter "K" with a square shape inside the letter. Below the letter "K" is the word "KURARAY" in a bold, sans-serif font. The logo is black and white.

+81-6-348-2603 Facsimile: +81-6-348-2552

Image /page/0/Picture/4 description: The image shows a handwritten string of characters. The string appears to be "KA982259". The characters are written in a cursive style with varying stroke thicknesses. The image has a white background.

510(K) SUMMARY

1. Submitter

KURARAY CO., LTD. 1) Name 1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan Address 2) 81(Japan)6-348-2603 Telephone 3) 81(Japan)6-348-2552 Facsimile 4) Contact person Yoshinori Nagase 5) Dental Material Department Medical Products Division Date June 25, 1998 6)

2. Representing (Subsidiary of KURARAY CO., LTD)

1) Name	KURARAY AMERICA Inc.
2) Address	30th FI. Metlife Building, 200 Park Avenue, NewYork, NY 10166
3) Telephone	(212)986-2230
4) Facsimile	(212)876-3543
5) Contact person	Koji FijitaPresident

3. Name of Device

1) Proprietary Name	CHROMA ZONE COLOR STAIN
2) Classification Name	Tooth shade resin material (21CFR 872.3690)

Classification Name 2) Resin-based stain material 3) Common/Usual Name
1. Predicate devices:

1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN ANDBRIDGRE FABRICATION SYSTEM by KERR CORP.	(K955331)
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	SOLIDEX by SHOFU DENTAL CORP.	(K972292)
5)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)
6)	DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUSKULZER INC.	(K940800)

5. Description for the premarket notification

This product is similar and substantially equivalent in design, composition and function to stain materials of the similar products which are identified in the paragraph 4 of this

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summary; all of which are safe, effective and beneficial.

1. Statement of the intended use.
  This device is used for developing color characterization of resin-based facing crown, jacket crown, and inlay and onlay restorations. The indication is same to that of stain materials in similar products.

1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN AND	(K955331)
	BRIDGRE FABLICATION SYSTEM by KERR CORP.
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	SOLIDEX by SHOFU DENTAL CORP.	(K972292)
5)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)
6)	DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS	(K940800)
	KULZER, INC.

Statement of the technological characteristics and safety CHROMA ZONE COLOR STAIN is developed to be used for color characterization in laboratory fabrication of resin-based jacket crown, facing crown, inlay and onlay. CHROMA ZONE COLOR STAIN is substantially equivalent in design, components and function to that of products sold in the U.S. market.

7-1 Components
CHROMA ZONE COLOR STAIN consists of 11 Stain Pastes, the Clear Paste and These components are similar to that of stain materials of the products in accessories. the paragraph 4 of this summary.

: 元 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : 7-2 Technological characteristics

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. CHROMA ZONE COLOR STAIN is substantially equivalent in intended use and performance to that of products sold in the U.S. market. There are two methods for color characterization. One method is to put a stain material to dentin resin and place enamel resin on it.(Inner stain technique) The other method is to put a stain material to pit and fissure site after shaping and polishing (Surface stain technique) CHROMA ZONE COLOR STAIN is used by these methods and the procedure is same to that of products sold in the U.S. market.

CHROMA ZONE COLOR STAIN is substantially equivalent in design, components and function to that of products sold in the U.S. market.

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7-3 Chemical ingredients

The chemical ingredients except BGP, DTA, JFB2 and JFB404 have been already used in the following products that is allowed to be sold in U.S. market.

1. CLEARFIL LINER BOND 2 by Kuraray Co., Ltd.		(K943169)
2. PANAVIA 21 by Kuraray Co., Ltd.		(K933030)
3. CLEARFIL POSTERIOR 3 by Kuraray Co., Ltd.		(K871635)
4. PHOTO CLEARFIL OPAQUER by Kuraray Co., Ltd.		(K925383)
5. TEETHMATE F-1 by Kuraray Co., Ltd.		(K965091)
6. CLEARFIL LINER BOND 2V by Kuraray Co., Ltd.		(K974486)
7. CLEARFIL AP-X by Kuraray Co., Ltd.		(K943168)
8. PANAVIA EX; A Dental Adhesive by Kuraray Co., Ltd.		(K855211)
9. DURAFILL MICROFILL RESTORATIVE MATERIALby Kulzer, Inc.		(K811669)
10. PRISMA-FIL by DENTSPLY INTL		(K801732)

Both JFB2 and JFB404 do not affect safety of CHROMA ZONE COLOR STAIN, because it is a food additive and a same pigment is listed as a color additive in 21 CFR. BGP is a borosilicate glass containing SiO2, B2O3, Al2O3, Na2O, K2O and Fe2O. These metallic oxides are used as ingredients of dental porcelain.

8. Summary of biological evaluation

The biocompatibility of BGP and DTA is as follows. These results suggest that CHROMA ZONE COLOR STAIN is a safe dental device.

8-1 BGP(used as inorganic filler)

8-1-1 Acute toxicity

1)	Animal	Mouse
2)	Dosing route	Oral
3)	Results	LD50: not less than 8,000 mg/kg

8-2 DTA(used as matrix resin)

8-2-1 Acute toxicity

1) Animal	Rat
2) Dosing route	Oral
3) Baseline	I.P. greater than 2,000 mg/kg

1. Results LD50; not less than 3,000 mg/kg

8-2-2 Genotoxicity test

1) Method	Ames test
2) Results	Negative

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Kuraray Co., Ltd. C/O Mr. Koji Fujita President Kuraray America, Incorporated 30th FI Metlife Building 200 Park Avenue New York, New York 10166-3098

Re: K982259 Trade Name: Chroma Zone Color Stain Requlatory Class: II EBF Product Code: Dated: June 26, 1998 Received: June 26, 1998

Dear Mr. Fujita:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register Please note: this response to your wow premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Fujita

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, unma Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: CHROMA ZONE COLOR STAIN

Indications for Use

Color characterization for:

1. Jacket crown
Facing crown 2)
1. Inlay and onlay

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ OR Over-The-Counter Use

(Optional Format 1-2-96)

Suva Runne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982259

Regulation Number and Section

§ 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.