The E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material is a light-cured, radiopaque, submicron-filled composite resin system for use in dental procedures such as anterior and posterior restorations including occlusal surfaces, direct bonded composite veneers, diastema closures, and the repair of porcelain/composites.
The E-1 ESTHETIC COMPOSITE SYSTEM is for use as a tooth shade resin material in dental procedures.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) summary for a dental device, the E-1 ESTHETIC COMPOSITE SYSTEM. This type of submission relies on demonstrating substantial equivalence to pre-existing devices, rather than conducting new clinical studies with defined acceptance criteria and extensive performance evaluations for standalone or human-in-the-loop performance. Therefore, many of the requested categories are not directly applicable or explicitly stated in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study with outcome measures. Instead, it relies on demonstrating substantial equivalence to predicate devices based on certain performance characteristics.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Flexural Strength	Comparable to predicate devices (K#980051 and K#051808)	"slightly different performance characteristics" but not raising new safety/effectiveness questions
Water Sorption	Comparable to predicate devices (K#980051 and K#051808)	"slightly different performance characteristics" but not raising new safety/effectiveness questions
Solubility	Comparable to predicate devices (K#980051 and K#051808)	"slightly different performance characteristics" but not raising new safety/effectiveness questions
Depth of Cure	Comparable to predicate devices (K#980051 and K#051808)	"slightly different performance characteristics" but not raising new safety/effectiveness questions
Biocompatibility	Demonstrated by common use of ingredients in similar devices	"All ingredients used in the E-1 ESTHETIC COMPOSITE SYSTEM are biocompatible, as demonstrated by their common use in similar dental devices"

Study Information:

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. This document refers to the characteristics of the device itself and its materials, rather than a "test set" of patients or data in a clinical trial. The evaluation is based on comparison to existing device specifications and material properties.
Data Provenance: Not applicable in the context of clinical trial data. The data pertains to the physical and chemical properties of the E-1 ESTHETIC COMPOSITE SYSTEM and its components, compared against documented properties of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in this context refers to established material science and biocompatibility standards, not expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable. There was no "test set" in the context of patient data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental material, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a dental material.

7. The type of ground truth used:

The "ground truth" for this submission is based on established material science standards, biocompatibility principles, and the documented performance characteristics of legally marketed predicate devices. The claim is that the E-1 ESTHETIC COMPOSITE SYSTEM's properties (flexural strength, water sorption, solubility, depth of cure, biocompatibility) are sufficiently similar to allow for a determination of substantial equivalence, meaning it raises no new questions of safety or effectiveness.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K07 2746

510(k) SUMMARY Tokuyama Dental Corporation E-1 ESTHETIC COMPOSITE SYSTEM

Name of Device

DEC 0 4 2007

Trade or Proprietary Name:	E-1 ESTHETIC COMPOSITE SYSTEM
Common Name:	tooth shade resin material
Classification Name:	material, tooth shade, resin
Product Code:	EBF

Preparation Date

September 12, 2007

510(k) Sponsor

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan

510(k) Sponsor Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

Intended Use

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Technological Characteristics and Substantial Equivalence

The E-1 ESTHETIC COMPOSITE SYSTEM device is substantially equivalent to multiple predicate devices (K#980051 and K#051808) with respect to flexural strength, water sorption, solubility, and depth of cure for various curing times. Although the E-1 ESTHETIC COMPOSITE SYSTEM device may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness. All ingredients used in the E-1 ESTHETIC COMPOSITE SYSTEM are biocompatible, as demonstrated by their common use in similar dental devices such as the predicate devices identified above.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, often associated with healthcare organizations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2007

Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, District of Columbia 20005

Re: K072746

Trade/Device Name: E-1 Esthetic Composite System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 26, 2007 Received: October 2, 2007

Dear Mr. Barritt:

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- Mr. Barritt

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 vour 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/industry/support/index.html.

Sincerely yours.

Sutte y. Michie o
m.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): unknown K072746

Device Name: E-1 ESTHETIC COMPOSITE SYSTEM

Indications for Use:

The E-1 ESTHETIC COMPOSITE SYSTEM is for use as a tooth shade resin material in dental procedures.

Prescription Use (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Thomas

Apostleship, Government,
of Daniel Davis.

KO72741

Page 1 of 1

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.