The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.

Device Description

The Yamahachi Teeth are anterior and posterior teeth that are intended to be used in removable dentures only. They are made up of three synthetic polymers including polymethlymethacrylate, polymethylmethacrylate-SiO2, and a composite resin urethane dimethacrylate-polymethylmethacrylate - SiO2. The Yamahachi Teeth are used in conjunction with a denture-base resin for construction of removable full and partial dentures. The teeth are intended to be used by dental professionals such as dentists and dental technicians. The Yamahachi line of teeth include various sizes, shapes, and shades of anterior and posterior preformed plastic teeth

AI/ML Overview

The Yamahachi Teeth did not undergo studies with acceptance criteria regarding diagnostic performance or human-AI reader comparisons, as it is a physical medical device (preformed plastic teeth for dentures), not an AI/software device. The provided text details the device's physical characteristics, intended use, and compliance with various international standards for dental materials.

Here's an analysis of the provided information, focusing on criteria relevant to physical medical devices, and noting where typical AI/software study criteria do not apply:

Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Standard	Reported Device Performance
Material Composition	Similar to predicate devices (methylmethacrylate or derivative)	Made from polymethlymethacrylate, polymethylmethacrylate-SiO2, and a composite resin urethane dimethacrylate-polymethylmethacrylate - SiO2.
Intended Use	As teeth in removable dentures.	Intended for use as teeth in removable dentures.
Biocompatibility	Compliance with EN ISO 7405:1997	Inferred compliance through testing against EN ISO 7405:1997.
Physical Properties (e.g., strength, durability for dental use)	Compliance with EN ISO 3336:1997, EN ISO 1567:1995	Inferred compliance through testing against EN ISO 3336:1997 and EN ISO 1567:1995.
Color Stability	Compliance with EN ISO 7491:2000	Inferred compliance through testing against EN ISO 7491:2000.
Designation System	Compliance with EN ISO 3950:1997	Inferred compliance through testing against EN ISO 3950:1997.

Study Information (as relevant for a physical medical device)

The information provided describes compliance with international standards for dental materials rather than a clinical study with a detailed test set, ground truth experts, or statistical performance metrics typically associated with AI/software devices.

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software device. For a physical product like denture teeth, "testing" refers to laboratory evaluations of material properties. The document does not specify sample sizes for these laboratory tests (e.g., how many teeth were tested for strength or color stability). The provenance is implied to be from the manufacturer's testing in the context of achieving ISO standard compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's material properties is established through adherence to standardized testing protocols (e.g., ISO standards), not expert consensus on diagnostic images.
Adjudication method for the test set: Not applicable. Material property tests follow established protocols; there is no "adjudication" in the sense of reconciling expert opinions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating diagnostic performance of imaging devices or AI algorithms with human readers. The Yamahachi Teeth are a physical product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This concept is for AI algorithms.
The type of ground truth used: For this physical device, "ground truth" refers to the established specifications and performance metrics outlined in the referenced international standards (e.g., EN ISO 3336:1997). The device's performance is measured against these objective, standardized criteria.
The sample size for the training set: Not applicable. The device is a physical product and does not involve AI model training.
How the ground truth for the training set was established: Not applicable.

Summary of "Study" Description:

The provided text details that "Extensive testing has been performed on the Yamahachi Teeth to demonstrate compliance" with several EN ISO standards. These standards (e.g., EN ISO 3336, EN ISO 7405, EN ISO 1567, EN ISO 3950, EN ISO 7491) define the requirements and test methods for synthetic polymer teeth, biocompatibility, denture base polymers, dental designation systems, and color stability of dental polymeric materials, respectively.

The submission asserts that the device is "substantially equivalent" to predicate devices based on its material composition and intended use, and its compliance with these recognized international standards for performance and safety. This compliance is the "proof" that the device meets the acceptance criteria for a physical medical device of this type. The 510(k) clearance by the FDA (K060507) confirms this substantial equivalence determination based on the provided testing and documentation.

Summary

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K060507 510(k) Summary for Valplast Yamahachi Teeth

1. SPONSOR APR 7 2006

Valplast International Corp. 34-30 31st Street Long Island, NY 11106

Contact Person: Peter Nagy Telephone: 1-718-361-7440

Date Prepared: February 23, 2006

2. DEVICE NAME

Proprietary Name: Yamahachi Teeth Common/Usual Name: Dentures Classification Name: Plastic preformed teeth for dentures

3. PREDICATE DEVICES

Heraeus Kulzer, Inc., Artic Plastic Teeth Dentures subject of K033628

Merz Dental GmbH Artegral and Polystar Selection Preformed Plastic Teeth subject of K030588

4. DEVICE DESCRIPTION

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5. INTENDED USE

The Valplast Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Yamahachi teeth are essentially identical to the predicate devices in that they are all made from methylmethacrylate or a derivative of methylmethacrylate. The proposed and predicate devices are offered in various sizes, shapes, and colors. Like the predicate devices, the Yamahachi Teeth are artificial resin teeth that are compatible with all denture base resins.

7. PERFORMANCE TESTING

Extensive testing has been performed on the Yamahachi Teeth to demonstrate compliance with EN ISO 3336:1997 Dentistry; Synthetic polymer teeth; EN ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials; EN ISO 1567:1995 Denture Base Polymers; EN ISO 3950:1997 Dentistry-Designation system for teeth and areas of the oral cavity; and EN ISO 7491:2000 Dental Materials-Determination of color stability of dental polymeric materials.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal features the logo of the U.S. Department of Health and Human Services. The logo includes a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

7 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Valplast International Corporation C/O Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K060507

Trade/Device Name: Yamahachi Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: February 23, 2006 Received: February 28, 2006

Dear Ms. McNamara-Cullinane:

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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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 (QS) 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" (21 CFR 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,

X.ute Y. Michau OMD

Chiu S. Lin, PhD 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): K060507

Device Name: Valplast Yamahachi Teeth

Indications for Use: The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suver Thorpe

Bay. General H

Texas

K060507

Regulation Number and Section

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.