K Number

Device Name

PMMA Block

Manufacturer

Huge Dental Material Co., Ltd.

Date Cleared

2020-11-03

(134 days)

Product Code

EBG EBI MQC

Regulation Number

872.3770

Intended 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).

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101029, K141421

Reference Devices

K141421

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a material (PMMA block) used in a CAD/CAM milling process. The description focuses on the material properties and its use in traditional dental fabrication techniques, with no mention of AI or ML for design, analysis, or processing.

Therapeutic

Yes
The device is used to create removable structures for therapeutic restorations like night guards, bite splints, and occlusal splints, which are used to treat or prevent conditions like bruxism or temporomandibular joint disorders.

Diagnostic

Explanation: The device, PMMA BLOCK, is described as a material for creating dental structures like crowns, bridges, and night guards using CAD/CAM milling technology. Its purpose is to manufacture custom-made products, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device is a physical block of PMMA material used in a CAD/CAM milling machine to create dental prostheses. It is a hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to create temporary or removable dental structures (crowns, bridges, dentures, splints) using milling technology. This is a manufacturing process for a medical device that will be placed in the mouth.
Device Description: The device is a block of PMMA material used as an intermediate product in the creation of custom-made dental prostheses.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to provide information about a patient's health status based on in vitro examination of specimens.

IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This PMMA block is a material used to fabricate a dental prosthesis, which is a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

EBG, EBI, MQC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

on teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professional
used in hospital, dental clinic and relevant places

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. (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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150432

Reference Device(s)

K141421

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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
	Company
Name	Device Name	510 (k)
NO.	Substantially
Equivalent (SESE)
Decision Date	Product
code
Primary
Predicate	Union Dental
S.A.	IDODENTINE Dental
Polymer Blank	K150432	08/14/2015	EBG, EBI,
MQC
Reference
Device	HUGE	PMMA Block	K141421	02/09/2015	EBG

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

5. Description of Device

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.

(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 Blank
K150432	PMMA Block
K141421
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 strength
ISO 10477 $\ge$ 50 MPa
ISO 20795-1 $\ge$ 65 MPa	Water absorption
ISO 10477 $\le$ 0.040 mg/mm³
ISO 20795-1 $\le$ 0.032 mg/mm³	Water solubility
ISO 10477 $\le$ 0.0075 mg/mm³
ISO 20795-1 $\le$ 0.0016 mg/mm³	Residual monomer content
ISO 20795-1 $\le$ 2.2%	Dimensional stability
ISO 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.

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 Polymer
Blank
K150432	PMMA Block
K141421
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 10993-5
Non cytotoxic	ISO 10993-5
Non 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.

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.