This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the way typically found for an AI/ML medical device. This document is a 510(k) summary for a dental material (ESTENIA C&B), which relies on substantial equivalence to predicate devices rather than a performance study against specific acceptance criteria for AI algorithms.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device. This document describes a dental material and its physical/mechanical properties, not an AI algorithm's performance against clinical endpoints.

The document states:

"The physical and mechanical properties of ESTENIA C&B are verified by evaluation test based on ISO 10477."

This suggests that compliance with ISO 10477 serves as the "acceptance criteria" for the physical and mechanical properties of the material. However, no specific numerical values or ranges are provided for these properties, nor are the reported results from the evaluation test detailed.

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

Not applicable for an AI/ML device. This document refers to the evaluation of a dental material. The "test set" would likely refer to samples of the material tested in a lab for physical and mechanical properties. No details on the sample size or data provenance (e.g., country of origin, retrospective/prospective) for these material tests are provided.

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

Not applicable. The ground truth for a dental material's physical and mechanical properties is typically established by standardized laboratory testing methods, not by expert consensus in a clinical setting.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not the context here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. MRMC studies are specific to evaluating AI's impact on human reader performance, which doesn't apply to a dental material.

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

Not applicable. This is not an AI algorithm. The performance described relates to the intrinsic physical and mechanical properties of the dental material.

7. The Type of Ground Truth Used

The ground truth for the device's properties is based on standardized laboratory testing methods, specifically those outlined in ISO 10477. In this context, "ground truth" refers to the objectively measured physical and mechanical properties of the material according to established international standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The material itself is "trained" through its manufacturing process to achieve certain properties.

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

Not applicable. As noted above, this isn't an AI/ML device. The "ground truth" for the material's properties is established through the ISO 10477 evaluation tests during development and quality control of the manufacturing process.

In summary, the provided 510(k) summary for ESTENIA C&B pertains to a dental material and relies on demonstrating substantial equivalence to predicate devices, primarily through chemical composition and physical/mechanical properties verified against an international standard (ISO 10477). It does not contain the type of AI/ML device performance study details requested.

Summary

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K642929

(K012707)

(K033267)

(K012737)

(K992645)

(K962878)

(K954115)

(K972292)

(K020131)

(K964578)

DEC - 6 2004

510(k) SUMMARY

1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Masaya SasakiDental Material Division
4) Date	October 18, 2004
5) Contact person in U.S.A.	Koji NishidaKuraray America, Inc.101 East 52nd Street, 26th Floor, New York, NY 10022Telephone: (212)-986-2230 (Ext.115)Facsimile: (212)-867-3543

1. Name of Device

Submitter

1) Proprietary Name	ESTENIA C&B
2) Classification Name	Tooth shade resin material (21CFR 872.3690)
3) Common/Usual Name	Polymer-based crown and bridge material

3. Predicate device:

The predicate products are;

a) Tooth shade resin material

1. ESTENIA
1. EPRICORD
1. CHROMA ZONE COLOR STAIN
1. SINFONY
1. TARGIS SYSTEM
1. ARTGLASS & KEVLOC
1. SOLIDEX
1. VENUS UNIVERSAL LIGHT CURING COMPOSITE
1. FIBREKOR

b) Other dental materials

1. CLEARFIL SE BOND by Kuraray Medical Inc. (K012442) 2. CONNECT by SYBRON DENTAL (K954689)
  INC.
SPECIALTIES, INC.
by Kuraray Medical Inc.

by Kuraray Medical Inc.

by IVOCLAR NORTH AMERICA,

by HERAEUS KULZER, INC.

by JENERIC/PENTRON, INC.

by SHOFU DENTAL CORP.

by ESPE DENTAL AG

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4. Device description and intended use

5. Statement of the technological characteristics and safety

Chemical ingredients, design, physical and mechanical properties, and safety are same as predicate devices in the USA.

The physical and mechanical properties of ESTENIA C&B are verified by evaluation test based on ISO 10477. Safety is also verified because all chemical ingredients are used in legally marketed predicate devices.

Therefore this device is safe, effective, and substantially equivalent with predicated devices.

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Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, with a staff and a serpent winding around it. The emblem is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Kuraray Medical, Incorporated C/O Ms. Koji Nishida Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K042929

Trade/Device Names: Estenia™ C&B Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBG Dated: October 18, 2004 Received: October 27, 2004

Dear Ms. Nishida:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Koji Nishida

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu S. Lin, PhD
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[ESTENIA C&B, Kuraray Medical Inc.]

1104 2929

Indications for Use

ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.

1. Facing cast crowns and facing cast bridges
1. Jacket crowns
1. Inlays and onlays
Bridges with frameworks 4)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Kein Miley for MSP

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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.