Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate dentures. 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 included in this submission.

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

Yamahachi Pink 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, closed and block type CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn and block type can be used for any milling machine with the appropriate and compatible CAM system.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, the Yamahachi Pink CAD/CAM Disk. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria derived from a study that quantifies specific performance metrics in a clinical context (e.g., accuracy, sensitivity, specificity for a diagnostic device).

Therefore, I cannot provide a direct answer to all parts of your request as it pertains to a medical device software approval process involving performance metrics, expert reads, and clinical study data. This document describes a material (PMMA disk) used for fabricating dentures, and its approval relies heavily on demonstrating equivalent physical and chemical properties and intended use to existing, approved materials.

However, I can extract the relevant information and explain why other sections of your request are not applicable for this type of device submission based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

Device: Yamahachi Pink CAD/CAM Disk
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture relining, repairing, or rebasing resin
Product Code: EBI
Regulatory Class: Class II

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

For a material like this, the "acceptance criteria" are typically the standards conformance and physical/chemical property equivalence to a predicate, not performance metrics like sensitivity or specificity.

Acceptance Criteria (from ISO Standards / Predicate Equivalence)	Reported Device Performance (Yamahachi Pink CAD/CAM Disk)
Physical Properties (ISO 10477:2004)	Met acceptance criteria of this standard.
Appearance (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Size/Diameter (min to max) (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Thickness (min to max) (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Color of Shades (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Flexural Strength (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Flexural Modulus (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Water Sorption (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Solubility (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Color Stability (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Translucency (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Residual MMA (ISO 20795-1:2013)	Tested and evaluated (implied acceptable as part of meeting standard).
Biocompatibility	Previously tested and established with FDA with cleared device K131036 (reference predicate).
Shelf Life	10 Years

Note on "Acceptance Criteria" for this device: The primary "acceptance criteria" for a 510(k) submission like this are demonstrating:

Same intended use as a predicate.
Same technological characteristics (or differences that do not raise new questions of safety or effectiveness).
Conformance to relevant performance standards (ISO standards in this case).

Regarding the "Study that proves the device meets the acceptance criteria":

The "study" here is non-clinical performance testing and comparison to predicates. It's not a clinical trial in the sense of a diagnostic AI device.

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

Sample Size: Not specified in the document for the material testing. ISO standards often specify minimum sample sizes for various tests, but the report only states "The subject and predicate have both completed ISO standardized testing and have passed."
Data Provenance: The material is manufactured by Yamahachi Dental Mfg., Co. in Japan. The testing was non-clinical (laboratory-based) and conducted to ISO standards.

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

Not Applicable. This is not a diagnostic device where "ground truth" is established by expert readers. The "ground truth" for a material like this is defined by adherence to validated ISO standards for physical and chemical properties.

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

Not Applicable. No human adjudication of results in the context of clinical reads is relevant for this material.

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 is not a diagnostic AI device subject to MRMC studies.

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

Not Applicable. This is not a medical device algorithm.

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

The "ground truth" is adherence to international consensus standards (ISO 10477:2004, ISO 20795-1:2013) for dental polymeric materials, combined with biocompatibility data from a previously cleared device (K131036) with identical chemical composition.

8. The sample size for the training set

Not Applicable. This device is a material, not an AI/ML algorithm requiring a training set.

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

Not Applicable. See point 8.

Summary

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Yamahachi Dental Mfg., Co. % Joyce St. Germain/Claude Berthoin Regulatory Dept. Manager/CEO Denterprise International, Inc./510k FDA Consulting 100 East Granada Blvd. Ormond Beach Florida 32176

January 16, 2018

Re: K172683

Trade/Device Name: Yamahachi Pink CAD/CAM Disk Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: December 4, 2017 Received: December 7, 2017

Dear Joyce St. Germain/Claude 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 of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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forTina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known)

Device Name Yamahachi Pink CAD/CAM Disk

Indications for Use (Describe) Yamahachi Pink CAD/CAM Disk is used for the fabrication of dentures.

Type of Use (Select one or both, as applicable)X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510k FDA Consulting

100 East Granada Blvd., Suite 219

Ormond Beach, FL 32176

386-506-8711

510(k) Summary

Submitter/Applicant K172683

Yamahachi Dental Mfg., Co. 54-1, Ochigara, Nishiura-Cho Gamamori-City, Aichi Pref, Japan 443-0105

Establishment Registration:
Phone:	+81-533-57-7121
Fax:	+81-533-57-1764
Primary Contact:	Shogo Muramatsu, muramatsu@yamahachi-dental.co.jp
Secondary Contact:	Kani Akifumi, kani@yamahachi-dental.co.jp

Date Prepared: August 30, 2017

Preparer/Consultant

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

Phone:	386-506-8711
Primary Contact:	Joyce St. Germain, Regulatory Dept Manager, joyce@510kfda.com
Secondary Contact:	Claude Berthoin, CEO, claude@denterpriseintl.com

Device Classification

Trade Name:	Yamahachi Pink CAD/CAM Disk
Common Name:	Pink CAD/CAM Disk
Classification Name:	Denture relining, repairing, or rebasing resin
Regulation Number:	21 CFR 872.3760
Product Code:	EBI
Class:	2

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Predicate Device

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

510(k) Number:	K153546
Trade Name:	Pink CAD/CAM Disc
Manufacturer:	Polident D.O.O.
Regulation Number:	21 CFR 872.3760
Product Code:	EBI

Reference Predicate Device

The following reference is a legally marketed, post-amendment device. This reference predicate is the same PMMA Disk (only the shade is different) and the same CAD/CAM system cleared that is used with the subject device.

510(k) Number:	K151764
Clearance Date:	November 23, 2015
Trade Name:	Yamahachi PMMA Disk
Manufacturer:	Yamahachi Dental Material Co., Ltd., China
Regulation & PC:	872.3770; EBG

Reference Predicate Device

The following reference is a legally marketed, post-amendment device. This reference predicate is identical chemical composition as the subject device made and cleared by Yamahachi with Resin Basis and Basis Hi devices.

510(k) Number:	K131036
Clearance Date:	July 12, 2013
Trade Name:	Yamahachi Denture Base Resins
Manufacturer:	Yamahachi Dental Mfg., Co., Japan
Regulation & PC:	872.3760; EBI

Indications for Use

YAMAHACHI Pink CAD/CAM Disk is used for the fabrication of dentures.

Intended Use

PMMA Disks are polymethyl methacrylate blanks used to mill dentures in various CAD/CAM systems.

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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	Pink Disk	Pink CAD/CAMDisc	NA
K number	K172683	K153546	NA
510(k) Owner	Yamahachi DentalMfg., Co. (Japan)	Polident D.O.O.	NA
Classification &Product Code	872.3760; EBI	872.3760; EBI	Same
Classification Name	Denture relining,repairing, or rebasingresin	Denture relining,repairing, or rebasingresin	Same
Common Name	PMMA CAD/CAM Disk	PMMA CAD/CAM Disk	Same
Device Description	Disks are milling blanksused in the fabricationof dentures.	Disks are milling blanksused in the fabricationof dentures	Same
Intended Use	PMMA Disks arepolymethylmethacrylate blanksused to mill denturesin various CAD/CAM	Fabrication ofdentures.	Same

Table 5 -- Technological Comparison

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	systems.
Indication For Use	YAMAHACHI PinkCAD/CAM Disk is usedin the fabrication ofdentures.	Fabrication of dentures.	Same

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
Fabrication	CAD/CAM technique	CAD/CAM technique	Same
General Description	Cross-linked PMMA-based resins withpigments for tinting	Cross-linked PMMA-based resins withpigments for tinting	Same
Configurations	Open--Disk;Closed--AmannGirrbach, Zirkonzahn,Block, Pin & 2 Pin	Closed and Block Disc	SameSubject also availablefor open disk use.
Components	PMMA with cross-linker and pigments	PMMA with cross-linker and pigments	Same
Biocompatibility	Previously tested andestablished with FDAwith cleared deviceK131036	PredicateBiocompatibilitycomplete for deviceclearance	Same

Non-clinical Performance testing

Physical Properties	ISO 10477:2004Met acceptancecriteria of thisstandard.	ISO 10477:2004	Same
Shelf Life	10 Years	Not determined	Subject exceedspractical shelf life

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ADDITIONAL: ISO 20795-1:2013 Dentistry - Denture base polymers. The subject device was also tested on the following according to the standard:

Appearance
Size/Diameter (minimum to maximum) ●
Thickness (minimum to maximum) ●
Color of Shades
Flexural Strength ●
Flexural Modulus ●
Water Sorption ●
Solubility ●
Color Stability
Translucency ●
Residual MMA

Substantial Equivalence

The above comparison chart shows the subject and predicate devices are substantially equivalent in technological characteristics.

The subject and predicate devices have the same material composition of PMMA Disks composed of polymethyl methacrylate, hot cured polymer.

The subject and predicate have the same function and the same intended use to fabricate the final products by CAD/CAM technique and have similar physical and chemical properties.

The subject and predicate are manufactured under the same technological process with the same raw material used.

The subject and predicate have both completed ISO standardized testing and have passed and the tests are in the comparison chart shown above.

Conclusion

The nonclinical tests demonstrate that the device is substantially equivalent to the predicate device since they have the same intended use, material composition, and performed as well in the physical properties testing. Therefore, Yamahachi Pink CAD/CAM Disk demonstrates that it is as safe, as effective, and performs as well as the predicate device and warrants a finding of substantial equivalence to the legally marketed predicate device.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.