PuRE PMMA Discs 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. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology. The discs are provided non-sterile, without any accessories, and are indicated for single use only. The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 Monochromatic colors and 20 multilayer colors all with varying thickness (14-40mm).

AI/ML Overview

The provided document is a 510(k) summary for a dental device, "PuRE PMMA Disc". It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain the specific information required to address most of your questions about acceptance criteria and the study that proves the device meets them. This document is a regulatory submission for market clearance, not typically a detailed report of clinical study results.

Here's an analysis of what can and cannot be answered from the provided text:

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

The document states:

"Physical Properties: Met the acceptance criteria of ISO 10477:2004 and JIS T 6518:2011"
"Biocompatibility: Biocompatible"

However, it does not provide a table detailing the specific acceptance criteria from ISO 10477:2004 and JIS T 6518:2011, nor does it report the concrete performance values the device achieved against these criteria (e.g., specific flexural strength values, water sorption, etc.). It only mentions that the criteria were met.

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

This information is not available in the provided text. The document refers to "non-clinical performance tests," but does not specify sample sizes for these tests or the origin/nature of the data.

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 information is not applicable/provided. The document primarily discusses material properties and biocompatibility, not diagnostic performance requiring expert interpretation for ground truth. It refers to "dental professionals and technicians" for designing and manufacturing restorations, but this is about the use of the device, not the establishment of ground truth for performance testing in the context of this regulatory submission.

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

This information is not applicable/provided for the same reasons as #3.

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 information is not applicable/provided. This device is a dental material (PMMA disc), not an AI-assisted diagnostic tool.

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

This information is not applicable/provided as it relates to an AI algorithm, which this device is not.

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

The "ground truth" for the device's performance is based on standardized mechanical and material property tests as defined by ISO 10477:2004 and JIS T 6518:2011, and biocompatibility assessments. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in the provided text for this submission.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical product, not an AI model that requires a training set.

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

This information is not applicable/provided for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 9, 2021

Quest Dental USA Corp. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th Street Suite 200 Gardena, California 90248

Re: K201563

Trade/Device Name: PuRE PMMA Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: January 13, 2021 Received: January 13, 2021

Dear Takahiro Haruyama:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@)tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K201563

Device Name PuRE PMMA Discs

Indications for Use (Describe)

Pure PMMA Discs are polymethy] methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary - K201563

5.1. Submitter Information

510(k)Owner/Applicant	Quest Dental USA Corp17865 Sky Park Circle, Ste. L1Irvine, CA 92614
OfficialCorrespondent	Takahiro HaruyamaGlobizz Corporation1411 W. 190th St., Ste. 200Gardena, CA 90248Tel: (310) 538-3860Email: register@globizz.net
Date Prepared	May 15, 2020

5.2. Device Identification

Trade Name	PuRE PMMA Disc
Common Name	PMMA Disc
ClassificationName	Temporary Crown and Bridge Resin
ClassificationRegulation	872.3770
Review Panel	Dental
Product Code	EBG
Device Class	Class II

5.3. Predicate and Reference Devices

PrimaryPredicate	510(k) No.: K172281Device Name: PuRE PMMA DiscSubmitter/Applicant: Quest Dental USA Corp.
ReferenceDevices forCompositionandBiocompatibility	510(k) No.: K172281Device Name: PuRE PMMA DiscSubmitter/Applicant: Quest Dental USA Corp.

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5.4. Device Description

The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 Monochromatic colors and 20 multilayer colors all with varying thickness (14-40mm):

Clear
A0	A1	A2	A3	A3.5	A4
	B1	B2	B3		B4
	C1	C2	C3		C4
		D2	D3		D4
	BL1	BL2	BL3		BL4	BL5

Table 1: PuRE PMMA Disc Monochromatic colors

		Table 2: PuRE PMMA Discs MultiLayer shade combinations
--	--	--------------------------------------------------------

MLA1	MLA2	MLA3	MLA4
MLB1	MLB2	MLB3	MLB4
MLC1	MLC2	MLC3	MLC4
	MLD2	MLD3	MLD4
MLBL1	MLBL2	MLBL3	MLBL4

5.5. Indications for Use Statement

5.6. Comparison of Device Characteristics

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	Subject Device	Predicate Device	Comparison
510(k) No.	K201563	K172281
Applicant	Quest Dental U.S.A.Corp.	Quest Dental USACorp.	--
Device Name	PuRE PMMA Disc	PuRE PMMA Disc	--
Regulation No.	21 CFR 872.3770	21 CFR 872.3770	Same
Product Code	EBG	EBG
Indications foruse	PuRE PMMA Discsare polymethylmethacrylate blanksused to mill dentallong-term temporarycrowns and bridgesin variousCAD/CAM systemsuntil permanentrestorations can bedelivered.Restorations aredesigned andmanufactured bydental professionalsand techniciansusing openCAD/CAMtechnology.	PuRE PMMA Discsare polymethylmethacrylate blanksused to mill dentallong-term temporarycrowns and bridgesin variousCAD/CAM systemsuntil permanentrestorations can bedelivered.Restorations aredesigned andmanufactured bydental professionalsand techniciansusing openCAD/CAMtechnology.	Same.
TechnologicalCharacteristics
How Device isMade	Powder and liquidmethacrylate-basedresins mixedtogether, and heatcured	Powder and liquidmethacrylate-basedresins mixedtogether, and heatcured	Same.
Composition	PMMA + pigments	PMMA + pigments	Same
Biocompatibility	Biocompatible	Biocompatible	Same.
PhysicalProperties	Met the acceptancecriteria of ISO10477:2004 and JIST 6518:2011	Met the acceptancecriteria of ISO10477:2004 and JIST 6518:2011	Same.

Table 3: Comparison of device characteristics to predicate and reference devices.

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5.7. Statement of Substantial Equivalence

The subject device and predicate devices are similar in their intended use, technological characteristics, and composition of construction materials. Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical performance tests demonstrate that the PuRE PMMA Disc is substantially equivalent to the referenced 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.