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.

Device Description

The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 shades and varying thicknesses (14-30 mm).

AI/ML Overview

This is a 510(k) summary for a dental device, specifically PMMA discs used for temporary crowns and bridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set) are not applicable or cannot be extracted from this document, as this type of submission generally relies on material properties testing and comparison to an already cleared predicate.

However, I can extract information related to the acceptance criteria for physical properties and details about the device's composition and manufacturing.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Standard)	Reported Device Performance (PuRE PMMA Disc)
ISO 10477:2004	Met the acceptance criteria
JIS T 6518:2011	Met the acceptance criteria

Study that proves the device meets the acceptance criteria:
The document states that "Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness." and "The conclusions drawn from the non-clinical performance tests demonstrate that the PuRE PMMA Disc is substantially equivalent to the referenced predicate device."

This implies a series of non-clinical, in-vitro tests were conducted according to the specified ISO and JIS standards to evaluate the physical properties of the PuRE PMMA Disc (e.g., flexural strength, water sorption, solubility, etc., as typically covered by these dental material standards). The results of these tests demonstrated compliance with the established thresholds within those international standards. The specific numerical performance values are not provided in this summary, only the statement of meeting the criteria.

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

Sample Size for Test Set: Not specified in the provided summary. This type of information would typically be in the detailed test reports attached to the 510(k) submission, not in the summary document itself.
Data Provenance: Not specified. Performance testing for material properties is typically conducted in a laboratory setting.

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)
Not applicable. This device is a material, not an AI/ML diagnostic or therapeutic device requiring expert interpretation for ground truth. Ground truth for material properties is established through standardized physical and chemical testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation outcomes, not for material property assessments.

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 an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be the established acceptable ranges for physical and chemical properties as defined by the international standards ISO 10477:2004 (Dentistry — Polymer-based restorative materials — Provisional dental materials) and JIS T 6518:2011 (Dental polymethyl methacrylate materials for CAD/CAM system).

8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K172281 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: August 3, 2017 Received: August 4, 2017

Dear Takahiro Haruyama:

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.

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 (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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 19, 2017

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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,

Mary S. Runner -S

for Tina 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)

K172281

Device Name PuRE PMMA Disc

Indications for Use (Describe)

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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SECTION 5: 510(k) Summary

5.1: Submitter Information

510(k) Owner/Applicant	Quest Dental USA Corp17865 Sky Park Circle, Ste. L1Irvine, CA 92614
Official Correspondent	Takahiro HaruyamaGlobizz Corporation1411 W. 190th St., Ste. 200Gardena, CA 90248Tel: (310) 538-3860Email: register@globizz.net
Date Prepared	July 21, 2017

K172281

5.2: Device Identification

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

5.3: Predicate and Reference Devices

Predicate Device	510(k) No.: K093708Device Name: TELIO® CADSubmitter/Applicant: Ivoclar Vivadent, Incorporated
Reference Devices forComposition andBiocompatibility	1. 510(k) No.: K151764Device Name: Yamahachi PMMA DisksSubmitter/Applicant: Yamahachi Dental Products USA, Inc2. 510(k) No.: K132937Device Name: Harvest Dental Polymer Blocks (ZCAD)Submitter/Applicant: Harvest Dental Products, LLC3. 510(k) No.: K973513Device Name: ESPE Sinfony Opaquer PowderSubmitter/Applicant: ESPE GMBH & CO. KG.

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5.4: Device Description

The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 shades and varying thicknesses (14-30 mm):

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

5.5: Indications for Use Statement

5.6: Comparison of Device Characteristics

	Subject Device	Predicate Device	Reference Devices	Comparison
510(k) No.	Not yet assigned	K093708	1. K1517642. K1329373. K973513	--
Applicant	Quest Dental U.S.A. Corp.	Ivoclar Vivadent	1. Yamahachi Dental Products USA, Inc.2. Harvest Dental Products, LLC3. ESPE GMBH & CO. KG.
Device Name	PuRE PMMA Disc	TELIO® CAD	1. Yamahachi PMMA Disks2. Harvest Dental Polymer Blocks (ZCAD)3. ESPE Sinfony Opaquer Powder
Regulation No.	21 CFR 872.3770	21 CFR 872.3770	1. 21 CFR 872.37702. 21 CFR 872.37703. 21 CFR 872.3690	The subject device is regulated the same as K093708, K151764, and K132937.
Product Code	EBG	EBG	1. EBG2. EBG3. EBF
Indications for use	PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent	For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.		Same.

Table 5-A. Comparison of device characteristics to predicate and reference devices.

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	restorations can bedelivered.Restorations aredesigned andmanufactured bydental professionalsand technicians usingopen CAD/CAMtechnology.
TechnologicalCharacteristics
How Device isMade	Powder and liquidmethacrylate-basedresins mixed togetherand heat cured	Powder and liquidmethacrylate-basedresins mixed togetherand heat cured		Same.
Composition	PMMA + pigments	PMMA + pigments	PMMA, pigments	The subjectdevice iscomposed ofthe same orsimilar materialsused in thepredicate andreferencedevices.
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Same.
PhysicalProperties	Met the acceptancecriteria of ISO10477:2004 and JIST 6518:2011.	Met the acceptancecriteria of ISO10477:2004		Same.

5.7: Statement of Substantial Equivalence

The subject and predicate devices are similar in 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.