YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.

Device Description

Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate temporary crowns and bridges. After polishing, the prosthesis is adjusted in the patient's mouth and cemented or bonded in place, where it remains until removal when the permanent restoration is available.

The restoration process begins in the dental office with an intraoral scan of the affected tooth and the surrounding teeth. Proprietary software takes this digital image and creates a replacement part for the missing areas of the tooth, creating a virtual restoration. The software sends this virtual data to a milling machine where the replacement part is carved out of a Yamahachi PMMA Disk. The optical impression system, software, and milling machine are not part of the device.

The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments.

Yamahachi PMMA Disks are available in different shapes and shades, with disks of all shades available in different dimensions (diameter, thickness and profile margin). It is intended for use in both open and closed CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn, block, pin and 2-pin.

AI/ML Overview

The provided document is a 510(k) summary for the Yamahachi PMMA Disks, a dental device. It outlines the device's classification, intended use, and a comparison with a predicate device to establish substantial equivalence. The document includes information on non-clinical performance testing.

Here's a breakdown of acceptance criteria and the study as requested:

1. A table of acceptance criteria and the reported device performance

Test Parameter	Acceptance Criteria (Standard)	Reported Device Performance	Outcome
Physical Properties	ISO 10477:2004	Met acceptance criteria of this standard	Met
Classification	ISO 10477	Type 2, Class 1 (Heat Cure Without Photo-Sensitive Initiator)	Same as predicate (implies meeting criteria)
Shelf Life	Not explicitly defined (for predicate)	10 Years	Subject exceeds practical shelf life (implies acceptable)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the non-clinical performance testing. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective. The testing is described as "Non-clinical Performance testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study is a non-clinical performance test for a material (PMMA Disks), not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" here is the adherence to material standards (ISO 10477:2004).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reason as point 3. Material property testing relies on objective measurements against a standard, not on expert 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

This section is not applicable. The device is a dental material (PMMA Disks), not an AI-driven or diagnostic device that would involve human readers or an MRMC study.

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

This section is not applicable. The device is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical performance testing was based on international material standards, specifically ISO 10477:2004 for "Dentistry -- Polymer-based restorative materials." Compliance with this standard served as the ground truth for acceptability.

8. The sample size for the training set

This section is not applicable. The 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 section is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 23, 2015

Yamahachi Dental Products USA, Inc. c/o Mr. Claude Berthoin Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormand Beach, FL 32176

Re: K151764

Trade/Device Name: Yamahachi PMMA Disks Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: October 14, 2015 Received: October 16, 2015

Dear Mr. Berthoin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K151764

Device Name Yamahachi PMMA DISKS

Indications for Use (Describe)

Y AMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.

Type of Use (Select one or both, as applicable)

x Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Submitter/Applicant

Yamahachi Dental Products USA, Inc. 160 Park Avenue Nutley, NJ 07110

Phone: 973-320-2909 Fax: 973-320-2995 Contact: Lawrence G. Greenwald (Yamahachi1 @yahoo.com) Date Prepared: June 23, 2015

Preparer/Consultant

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: 386-672-0450 eFax: 855-235-7902 Contact Person: Joyce St. Germain, Regulatory Executive

Device Classification

Trade Name:	Yamahachi PMMA Disks
Common Name:	PMMA Disks
Classification Name:	Temporary Crown and Bridge Resin
Regulation Number:	21 CFR 872.3770 Class II
Product Code:	EBG

Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

510(k) Number:	K093708
Trade Name:	Telio CAD
Manufacturer:	Ivoclar Vivadent, Inc. (Amherst, NY, USA)
Regulation Number:	21 CFR 872.3770
Product Code:	EBG

Indictions for Use

YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental longterm temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.

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Device Description

The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments.

Comparison of Technological Characteristics with Predicate

The following table compares technological and other characteristics of the subject and predicate device.

	Subject Device	Predicate Device	Comparison
Device	PMMA Disk	Telio CAD	NA
510(k) Owner	Yamahachi DentalProducts (USA)	Ivoclar Vivadent(Germany)	NA
Classification &Product Code	872.3770; EBG	872.3770; EBG	Same
Device Description	Temporary Crown AndBridge Resin	Temporary Crown AndBridge Resin	Same
Common Name	PMMA Disk	PMMA Disk	Same
Intended Use	Milling blanks forfabrication of long-term temporarycrowns & bridges inCAD/CAM systems.	Milling blanks forfabrication of long-term temporarycrowns & bridges inCAD/CAM systems.	Same

Table 5 -- Technological Comparison

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Indication For Use	YAMAHACHI PMMADISKS are polymethylmethacrylate blanksused to mill dental long-term temporary crownsand bridges in variousCAD/CAM systemsuntil permanentrestorations can bedelivered.	For the fabrication oftemporary crowns andbridges usingCAD/CAM technologyuntil permanentrestoration can bedelivered.	Same
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Technological

Characteristics
Product State	Solid	Solid	Same
How Device Is Made	Powder + Liquidmethacrylate-basedresins mixed togetherand heat cured	Powder + Liquidmethacrylate-basedresins mixed togetherand heat cured	Same
General Description	Cross-linked PMMA-based resins withpigments for tinting	Cross-linked PMMA-based resins withpigments for tinting	Same
Configurations	Open--Disc; Closed--Amann Girrbach,Zirkonzahn, Block, Pin& 2 Pin	Closed--Block, Disc	Subject used in open aswell as closed systems;not a meaningfuldifference.
Components	PMMA with cross-linker and pigments	PMMA with cross-linker and pigments	Same

Non-clinical Performance testing

Physical Properties	ISO 10477:2004Met acceptancecriteria of thisstandard.	ISO 10477:2004	Same
Classification(ISO 10477)	Type 2, Class 1 (HeatCure Without Photo-Sensitive Initiator)	Type 2, Class 1 (HeatCure Without Photo-Sensitive Initiator)	Same
Shelf Life	10 Years	Not determined	Subject exceedspractical shelf life

The above comparison shows the subject and predicate devices have substantially similar technology characteristics.

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Conclusion

The nonclinical tests demonstrate that the device is substantially equivalent to predicate device since they have the same intended use, material composition, and performed as well in physical properties testing; therefore, Yamahachi PMMA Disks warrants a finding of substantial equivalence to the legally marketed predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.