The Acrylic Block is a solid block of an acrylic polymer block that includes small quantities of color pigments. This Acrylic Block is a high polymer material made from quality poly methyl methacrylate. Poly (methyl methacrylate) is commonly used for thermopolymerizable acrylic resin denture bases because of its properties, including color and durability. In vitro tests have also shown its biocompatibility and enhancement of flexural behavior properties.

To fabricate the denture base, the Acrylic Block is milling machine utilizing the CAM data. After a 3D denture image is structured using the 3D CAD software, the artificial teeth are factored out, and a 3D denture base image is obtained. The Acrylic Block is then milled to the shape of the denture base. The artificial teeth are then bonded to the milled denture base using a bonding material and polished.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the "Acrylic Block" device, a cured base acrylic resin used to fabricate dentures. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study purely on the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable in the context of this traditional medical device submission. The submission relies on non-clinical (bench) testing and established standards for materials.

However, I can extract and present the relevant information that is available, framed within the context of a traditional device submission.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Acrylic Block (K143265)

The "Acrylic Block" device is a cured base acrylic resin intended for fabricating dentures. Its regulatory submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device (Yamahachi Denture Base Resins - K131036) by showing comparable material properties and biocompatibility, rather than assessing diagnostic performance or clinical effectiveness through human reader studies.

The acceptance criteria for this device are established through compliance with recognized international and national standards for dental materials, specifically focusing on biocompatibility and mechanical properties. The "study" proving the device meets these criteria consists of a series of non-clinical, bench-top tests.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Standard Reference)	Reported Device Performance (Acrylic Block)
Biocompatibility	EN ISO 7405:1997 / ISO 7405:2008: Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, test methods for dental materials. ISO 10993-1:2009: Biological evaluation of medical devices - Part 1: Evaluation and testing. ISO 10993-5 (Cytotoxicity): Non-cytotoxic. ISO 10993-10 (Skin Sensitization): No sensitization. ISO 10993-10 (Intracutaneous Reactivity): Not irritant. ISO 10993-11 (Subchronic Toxicity): No significant systemic toxicity. ISO 10993-3 (Genotoxicity - Chromosome Aberration): Non-clastogenic. ISO 10993-3 (Genotoxicity - AMES Test): Non-mutagenic (non-genotoxic and non-clastogenic).	- Non-cytotoxic: Met acceptance criteria per ISO 10993-5, JIS T 6001, Yakushokukihatsu No. 0301-20. - No Sensitization: Considered to cause no sensitization per ISO 10993-10, IIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. - Not Irritant: Caused no signs of irritation and met requirements per ISO 10993-10, JIS T 6001, and Yakushokukihatsu No. 0301-20. - No Significant Systemic Toxicity: Considered to not cause significant systemic toxicity per ISO 10993-11, JIS T 6001, Yakushokukihatsu No. 0301-1. And Yakushokukihatsu No. 0301-20. - Non-clastogenic: Considered non-clastogenic per ISO 10993-3, JIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. - Non-mutagenic: Considered non-mutagenic per ISO 10993-3, JJST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
Mechanical Properties	EN ISO 1567:1995: Denture Base Polymers. ISO 20795-1: Dentistry -- Base polymers -- Part 1: Denture base polymers. ANSI/ADA Specification No. 12:2002 (Reaffirmed 2008): Denture Base Polymers (including surface characteristics, color, translucency, freedom from porosity, flexural strength, flexural modulus, residual methyl methacrylate monomer, sorption and solubility).	- Met all acceptance criteria for denture base polymers as outlined in ISO 20795-1 and ANSI/ADA Specification No. 12:2002. - Demonstrated substantially similar performance to predicate denture base resins during non-clinical bench testing.
Risk Management	ISO 14971: Medical devices - Application of risk management to medical devices.	- Risk analysis conducted. Outcomes considered acceptable, and all potential risks mitigated to the lowest form.
Quality Systems	ISO 9001:2007 ISO 13485:2002	- Confirmed compliance (as listed for both subject and predicate device).

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

Sample Size: The document does not specify a numerical "sample size" in terms of patients or independent data points originating from specific cases, as would be common for AI/ML or clinical studies. Instead, samples refer to material specimens created and tested according to the requirements of the cited ISO and ANSI/ADA standards. These standards typically define the number of test specimens required for each specific mechanical or biological test (e.g., a certain number of flexural bars, cytotoxic extracts, etc.). The exact number for each test is not detailed in this summary.
Data Provenance: Not applicable in the traditional sense of patient data. The data originates from laboratory testing (bench testing) performed on material specimens of the Acrylic Block. The location of these testing facilities is not explicitly stated but would typically be in certified labs in Japan (Sun Medical Co. Ltd.'s country of origin) or elsewhere. The testing is prospective in the sense that it was conducted specifically for this submission against established standards.

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

Number of Experts & Qualifications: Not applicable. For material science and biocompatibility testing, "ground truth" is established by adherence to validated standardized test methods (e.g., ISO, ANSI/ADA) and objective measurements by trained laboratory personnel, rather than expert consensus on interpretive tasks. The results are quantitative measurements or assessments of biological reactions.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Material testing results are typically objective measurements or observations (e.g., cell viability; flexural strength in MPa, absence/presence of irritation) and do not involve human interpretation or adjudication in the way clinical image analysis might.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess if the device improves reader performance. The Acrylic Block is a material used for fabrication, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. The Acrylic Block is a physical material, not an algorithm or software device. Its "performance" is assessed through its inherent physical, chemical, and biological properties, not a standalone algorithmic output.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's evaluation is derived from objective, quantitative measurements and standardized biological assays as defined by the referenced international and national standards (ISO, ANSI/ADA, JIS). For example:
- Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity as determined by specific, validated lab tests (e.g., MEM Elution, Guinea Pig Maximization, Intracutaneous Reactivity, Chromosome Aberration Test, AMES Test).
- Mechanical Properties: Quantitative values for flexural strength, flexural modulus, sorption, solubility, etc., measured against specified thresholds in the standards like ISO 20795-1 and ANSI/ADA 12.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The Acrylic Block is not an AI/ML device that requires a "training set" to learn from data.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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

April 14, 2015

Sun Medical Co. Ltd. c/o Carrie Hetrick, D.D.S. Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K143265

Trade/Device Name: Acrylic Block Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Code: EBI Dated: March 6, 2015 Received: March 10, 2015

Dear Dr. Hetrick:

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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Page 2 - Carrie Hetrick, D.D.S.

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 vours.

Tina
Kiang -S

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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Indications for Use

510(k) Number (if known) K143265

Device Name Acrylic Block

Indications for Use (Describe)

Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary

for

Acrylic Block

1. Submission Sponsor

Sun Medical Co., Ltd. 571-2, Furutaka-cho Moriyama, Shiga 524-0044 Japan Phone: 81-77-582-9978 Fax: 81-77-582-9984 Contact: Mr. Yukihito Yukimune, Pharmaceutical Affairs Department Director

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 833.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

April 14, 2015

4. Device Identification

Trade/Proprietary Name:	Acrylic Block
Common/Usual Name:	Denture Base Resin
Classification Name:	Denture Relining, Repairing, or Rebasing Resin
Classification Regulation:	21 CFR § 872.3760
Product Code:	EBI
Device Class:	Class II
Classification Panel:	Dental

5. Legally Marketed Predicate Device(s)

Yamahachi Dental Manufacturing Co., Yamahachi Denture Base Resins- K131036

6. Device Description

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acrylic resin denture bases because of its properties, including color and durability. In vitro tests have also shown its biocompatibility and enhancement of flexural behavior properties.

7. Indication for Use Statement

Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture.

8. Substantial Equivalence Discussion

The following table compares the Acrylic Block to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Sun Medical Co., Ltd.	Yamahachi Dental ManufacturingCo.
Trade Name	Acrylic Block	Yamahachi Denture BaseResins
510(k) Number	K143265	K131036
Product Code	EBI	EBI
Regulation Number	21 CFR § 872.3760	21 CFR § 872.3760
Regulation Name	Denture Base Resin	Denture Base Resin
Device Description	It is used for creation of a denturebase with a computer-aided-design and computer-aided-manufacturing unit.	Traditional heat-cure andmicrowave-cure acrylic resign fortotal or partial denture base andfor removable prosthesis
Indications for Use	Acrylic Block is a cured base acrylicresin that is indicated for use tofabricate a denture.	Yamahachi Denture Base Resinsis a system of heat- and self-cureacrylic polymers intended forfabrication or repair of the denturebase.
Composition of Material -	Block made by Methyl	Polymer powder and monomer
the chemical composition ofthe device	methacrylate (MMA) monomer	liquid
Polymerization (Curing)Method	Acrylic Blocks polymerization iscompleted by heat curing methodat 20° C to 80° C.	Water Bath: Immerse flask inwater & slowly raise to boilingover 30 min, boil 30-40 min, aircool 30 min (Basis & Basis HI);Curing: Immerse flask in boilingwater 30 min (Basis TC)
Components	PMMA, initiator, pigments	Powder: PMMA, MMA (Basis Hi),Initiator, pigmentsLiquid:-MMA, Crosslinker, activator(Basis TC)
Standards of Conformity	ISO 9001:2007, ISO 13485:2002	ISO 9001:2007, ISO 13485:2002

	Table 5A - Comparison of Characteristics
--	------------------------------------------	--	--

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Manufacturer	Sun Medical Co., Ltd.	Yamahachi Dental Manufacturing Co.
Trade Name	Acrylic Block	Yamahachi Denture Base Resins
	ISO 14971	ISO 14971
Biocompatibility	ISO 10993-1, ISO 7405	ISO 10993-1, ISO 7405
Physical Properties	ISO 20795-1, ANSI/ADA 12:2002	ISO 20795-1

9. Non-Clinical Performance Data

Extensive testing has been performed on the subject denture base resin to demonstrate compliance with EN ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials; and EN ISO 1567:1995 Denture Base Polymers. The following testing has been performed to support substantial equivalence:

Biocompatibility -The biocompatibility of the Acrylic Block was evaluated in accordance with ISO 7405:2008, ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a permanent exposure (C), surface-contacting device in contact with mucosal membranes. The Sun Medical Acrylic Block biocompatibility was tested for the following with the final results.

. Cytotoxicity (MEM Elution Test) – The Acrylic Block was found to be non-cytotoxic and all test method acceptance criteria were met per ISO 10993-5, JIS T 6001, Yakushokukihatsu No. 0301-20.
. Skin Sensitisation (Guinea Pig Maximization) - Acrylic Block is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10, IIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
Intracutaneous Reactivity - Acrylic Block caused no signs of irritation, met the requirements of the test, and is classified as not irritant per ISO 10993-10, JIS T 6001, and Yakushokukihatsu No. 0301-20.
. Subchronic Toxicity - Acrylic Block is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11, JIS T 6001, Yakushokukihatsu No. 0301-1. And Yakushokukihatsu No. 0301-20.
. Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Acrylic Block extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3, JIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
. Genotoxicity Bacterial Reverse Mutation (AMES) Test - Acrylic Block was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3, JJST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.

Mechanical Testing – Performance testing of the Acrylic Block included testing for denture base polymers and copolymers in ISO 20795-1, Dentistry -- Base polymers -- Part 1: Denture

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base polymers, ISO 22112 Dentistry - Artificial teeth for dental prostheses, and ANSI/ADA Specification No. 12 - Denture Base Polymers.

Performance testing was conducted to evaluate the mechanical properties of the Acrylic Block. Specimens for each test were made according to the ADA/ANSI Specification No. 12: 2002 (Reaffirmed 2008) Denture Base Polymers to evaluate the subject devices flexural and tensile strengths, and fracture toughness. The subject device was also examined the ADA specification for surface characteristics, color, translucency, freedom from porosity, flexural strength, flexural modulus, residual methyl methacrylate monomer, sorption and solubility. It was concluded that the Acrylic Block met all acceptance criterion and hence are substantially equivalent to Yamahachi Denture Base Resins in terms of mechanical properties. It was also concluded that the Sun Medical Acrylic Block show a substantially similar performance other predicate denture base resins during non-clinical bench testing.

Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.

PMMA resin continues to be the universal, versatile polymer in prosthetic dentistry. The Acrylic Block has the same biological performance as predict PMMA resins.

As part of demonstrating that the Acrylic Block is substantially equivalent to predicate devices that are subject to this 510(k) submission, Sun Medical Co., Ltd. completed a number of tests. The Acrylic Block meets all the requirements for overall design and biocompatibility confirms that the output meets the design inputs and specifications. The Acrylic Block passed all testing stated above as shown by the acceptable results obtained in accordance with national and international standards.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The Acrylic Block has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. The Acrylic Block, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.

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.