PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

Temporary anterior and posterior crowns;
Temporary anterior and posterior bridges;
Implant surgical guide;
Removable structures for dentures;
Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

Device Description

PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.

AI/ML Overview

The provided text is a 510(k) summary for the PMMA Block, a dental material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or machine learning performance. The "acceptance criteria" discussed in the document pertain to the physical and chemical properties of the PMMA Block and its compliance with ISO standards for dental materials.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria for AI performance and reported device performance.
Sample sizes, data provenance, number of experts for ground truth, adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Type of ground truth used related to AI.
Training set sample size or how ground truth for training was established.

The document focuses on the material's properties, chemical composition, and manufacturing process, asserting substantial equivalence to existing dental materials, not on the performance of an AI-powered device.

Summary of relevant information from the document (not directly answering the AI-related questions):

Device: PMMA Block (dental polymer blanks)
Purpose: For making removable or temporary dental structures (crowns, bridges, surgical guides, dentures, night guards/bite splints) using CAD/CAM milling.
Study Type: This is a 510(k) premarket notification based on substantial equivalence to predicate devices, not a clinical performance study of a novel AI or medical imaging device.
"Acceptance Criteria" presented: Primarily physical and chemical properties of the material, tested against ISO standards (ISO 10477, ISO 20795-1, ISO 22112).
- Flexural strength: The new device must meet $\ge$ 50 MPa (ISO 10477) and $\ge$ 65 MPa (ISO 20795-1).
- Water absorption: The new device must meet $\le$ 0.040 mg/mm³ (ISO 10477) and $\le$ 0.032 mg/mm³ (ISO 20795-1).
- Water solubility: The new device must meet $\le$ 0.0075 mg/mm³ (ISO 10477) and $\le$ 0.0016 mg/mm³ (ISO 20795-1).
- Residual monomer content: The new device must meet $\le$ 2.2% (ISO 20795-1).
- Dimensional stability: The new device must meet within $\pm$ 2% of original mesio-distal dimension (ISO 22112).
Reported Device Performance (from Table 4):
- Flexural strength: $\ge$ 50 MPa and $\ge$ 65 MPa (meeting the criteria).
- Water absorption: $\le$ 0.040 mg/mm³ and $\le$ 0.032 mg/mm³ (meeting the criteria).
- Water solubility: $\le$ 0.0075 mg/mm³ and $\le$ 0.0016 mg/mm³ (meeting the criteria).
- Residual monomer content: $\le$ 2.2% (meeting the criteria).
- Dimensional stability: 0.29% (meeting the criteria of $\pm$ 2%).
Biocompatibility: Tests were performed according to ISO 10993 standards (Systemic Toxicity, Irritation, Sensitization, Cytotoxicity, In Vitro Mammalian Cell TK Gene Mutation Test, In Vitro mammalian chromosome aberration test, and Bacterial reverse mutation study). The document states the device is "Non cytotoxic."
Clinical Performance Data: "Not applicable. Clinical performance testing has not been performed for the subject device." (Section 10).

Summary

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Image /page/0/Picture/0 description: The image contains 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.

November 3, 2020

Huge Dental Material Co., Ltd. Maggie Zheng Regulatory Affairs Manager Middle Shanhai Road Rizhao City, Shandong Province 276800 China

Re: K201683

Trade/Device Name: PMMA Block Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, EBI, MQC Dated: July 31, 2020 Received: August 5, 2020

Dear Maggie Zheng:

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201683

Device Name PMMA BLOCK

Indications for Use (Describe)

PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

Temporary anterior and posterior crowns;
Temporary anterior and posterior bridges;
Implant surgical guide;
Removable structures for dentures;
Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

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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K201683_510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

1. Date Summary Prepared: November 3, 2020

2. Submitter Information:

Name	HUGE DENTAL MATERIAL CO., LTD.
Address	Middle Shanhai Road, Rizhao City, Shandong Province,276800, P.R. China
Telephone	086-633-2277285
Fax	086-633-2277298
Contact Person	Mrs. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: PMMA BLOCK Common name: Dental polymer blanks (discs or blocks) Classification name: Temporary Crown and Bridge Resin (21 C.F.R. 872.3770) Regulatory Class: II Product Code: EBG, EBI, MQC

4. Substantially Equivalent Device

Table 1: Predicate Device Information
	CompanyName	Device Name	510 (k)NO.	SubstantiallyEquivalent (SESE)Decision Date	Productcode
PrimaryPredicate	Union DentalS.A.	IDODENTINE DentalPolymer Blank	K150432	08/14/2015	EBG, EBI,MQC
ReferenceDevice	HUGE	PMMA Block	K141421	02/09/2015	EBG

These predicate devices have not been subject to a design-related recall.

5. Description of Device

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6. Indications for use

PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

Temporary anterior and posterior crowns;
Temporary anterior and posterior bridges;
Implant surgical guide;
Removable structures for dentures;
Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

7. Summary of Physical and Chemical Properties Tests

Chemical Composition: ●
The device has similar chemical composition as the predicate device (Polymethylmetacrilate, commonly named as PMMA, the same PMMA that is used for produce HUGE Synthetic Polymer Teeth and HUGE PMMA Block).
Technological characteristics:
The device has the same technological characteristics as the predicate device (Hot cured PMMA). And the device is similar in sizes, shapes and color scale as the predicate devices.
· Properties:
The device has comparable physical and chemical properties as the predicate device.

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(Meeting the requirements of ISO standards for the polymer-based dental materials,

ISO 10477, 20795-1, 22112)

Usage:
The device has similar indications for use as the sum of the predicate devices: making removable or temporary dental structures such as crowns and bridges by CAD/CAM or removable dental structures like denture bases and bite splints.

8. Technological Characteristics:

The new device, PMMA BLOCK, has the same design, materials and chemical composition as the predicate device.

Table 4: Device Comparison Table
Comparison Items	New Device	Primary Predicate	Reference Device
	PMMA BLOCK	IDODENTINE Dental Polymer BlankK150432	PMMA BlockK141421
1) Regulatory Classifications	same	same	Not applicable. This reference device only used to confirm the substantial equivalence regarding the raw materials.
2) Indications for use	similar	similar
3) Contraindications	same	same
4) Composition of Materials	PMMA	PMMA	PMMA
5) Physical Properties	Physical parameters	Flexural strengthISO 10477 $\ge$ 50 MPaISO 20795-1 $\ge$ 65 MPa	Water absorptionISO 10477 $\le$ 0.040 mg/mm³ISO 20795-1 $\le$ 0.032 mg/mm³	Water solubilityISO 10477 $\le$ 0.0075 mg/mm³ISO 20795-1 $\le$ 0.0016 mg/mm³	Residual monomer contentISO 20795-1 $\le$ 2.2%	Dimensional stabilityISO 22112 The dimensional change shall be within±2% of its original mesio-distal dimension.
	Predicate Device (K150432)	90 MPa	0.026 mg/mm³	0.0000 mg/mm³	1.4%	0.32%
	PMMA BLOCK	$\ge$ 50 MPa$\ge$ 65 MPa	$\le$ 0.040 mg/mm³$\le$ 0.032 mg/mm³	$\le$ 0.0075 mg/mm³$\le$ 0.0016 mg/mm³	$\le$ 2.2%	0.29%
	6) Labeling		similar	similar
	7) Target Population		dental patients	dental patients	Not applicable. This reference device only used to confirm the substantial equivalence regarding the raw materials.
8) Anatomical Site		on teeth	on teeth
9) Where Used		used in hospital, dental clinic and relevant places	used in hospital, dental clinic and relevant places
10) Human Factors		dental professional	dental professional
Note: The reference device is only used to confirm the substantial equivalence regarding the raw materials.

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Image /page/6/Picture/0 description: The image shows the word "HUGE" in large, bold, orange letters. The letters are slightly rounded and have a subtle shadow effect, giving them a three-dimensional appearance. The word is set against a plain white background, which makes the orange color stand out prominently.

Table 4: Device Comparison Table
Comparison Items	New Device	Primary Predicate	Reference Device
	PMMA BLOCK	IDODENTINE Dental PolymerBlankK150432	PMMA BlockK141421
11) Design	Circular solid (disc) or rectangular solid (block) of PMMA	Circular solid (disc) or rectangular solid (block) of PMMA
12) Cautions	similar	similar
13) Standards Met	same	same
14) Biocompatibility	ISO 10993-5Non cytotoxic	ISO 10993-5Non cytotoxic
15) Sterility	Non-sterile	Non-sterile
16) Chemical Safety	similar	similar

9. Summary of Biocompatibility

The new device, PMMA BLOCK, is substantially equivalent to the predicate devices that have been on the market for years and with no clinical adverse events. The formulation of new device does not contain any new or non-conventional chemicals compared to the legally marketed predicate device.

We selected our PMMA BLOCK (Model: Multilayer; Specification: 98×20mm; Shade: A4) as the representative in biocompatibility tests and those biocompatibility test reports can be used in the biological evaluation of PMMA BLOCK.

Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test items include Systemic Toxicity; Irritation; Sensitization; Cytotoxicity; In Vitro Mammalian Cell TK Gene Mutation Test; In Vitro mammalian chromosome aberration test and Bacterial reverse mutation study.

10. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed for the subject device.

11. Summary of Substantial Equivalence

As with the comparison shown in substantial equivalence discussion, these devices are same or similar in almost all aspects. In addition, the new device adds indications for use of night guards compared to the predicate device which falls into the last intended use of removable structures for therapeutic restorations. The details of physical properties are slightly different, but these two devices are in compliance with the ISO 10477, ISO 20795-1 and ISO 22112.

It can be seen that the minor differences between the new device and the predicate device are not of significance and do not raise different questions of safety and effectiveness as compared to the predicate device. We conclude that our PMMA BLOCK is substantially equivalent to the predicate device described herein.

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Image /page/7/Picture/0 description: The image shows the word "HUGE" in large, orange letters. Below the word is a black line, and below the line is the text "12. Photo of the device" in black font. The text is likely a heading or caption for a photo of a device.

Image /page/7/Picture/1 description: The image shows a collection of dental training materials. There are several pink and beige circular shapes, some clear plastic pieces, and a set of small, rectangular blocks. Additionally, there are some dental models and tools, all arranged on a white surface.

Image /page/7/Picture/2 description: The image shows a set of dentures. The dentures are pink and white and are set in a mold. The mold is beige and pink and is shaped like a mouth.

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.