Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Denture Base Polymers." It's a submission to the FDA (U.S. Food & Drug Administration) to demonstrate that the device is "substantially equivalent" to legally marketed predicate devices, meaning it's as safe and effective as a device already on the market.

However, the provided text does not describe a study involving "acceptance criteria" and "device performance" in the context of an AI/algorithm-based diagnostic or prognostic device. It's for a dental material (denture base polymers), which is a physical product, not a software or AI device.

Therefore, I cannot extract the information required for your request, such as a table of acceptance criteria for AI performance, sample sizes for test sets in an AI study, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

Chemical composition of the denture material.
Technological characteristics (e.g., heat curing, self-curing).
Physical and chemical properties that meet ISO standards (ISO 20795-1 for Dental base material).
Biocompatibility testing (following ISO 10993 standards) to ensure it's safe for use in the human body.
Comparison to predicate devices to demonstrate substantial equivalence for its intended use (fabrication and repair of partial and full denture base).

It explicitly states: "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies in the sense of a performance study for an AI device were conducted or are being reported here.

Summary

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August 12, 2022

Shandong Huge Dental Material Corporation Maggie Zheng Regulatory Affairs Manager No. 68 Shanhai Road, Donggang District Rizhao City, Shandong 276800 China

Re: K220680

Trade/Device Name: Denture Base Polymers Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: April 27, 2022 Received: May 2, 2022

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.

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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 (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 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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K220680

Device Name Denture Base Polymers

Indications for Use (Describe)

Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.

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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005 510 (k) Summary K220680

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

1. Date Summary Prepared: July 20, 2022

2. Submitter Information:

Name	Shandong Huge Dental Material Corporation
Address	No. 68 Shanhai Road, Donggang District, Rizhao City, ShandongProvince, 276800, P.R. China
Telephone	086-633-2277268
Contact Person	Ms. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: Denture Base Polymers Common name: Dental base material Classification name: resin, denture, relining, repairing, rebasing (21 C.F.R. 872.3760) Regulatory Class: II Product Code: EBI

4. Substantially Equivalent Device

Company Name	Device Name	510 (k)NO.	SubstantiallyEquivalent (SESE)Decision Date	Product code	Remarks
VERTEX-DENTALBV	Vertex RapidSimplified	K102654	12/03/2010	EBI	PrimaryPredicate
VERTEX-DENTALBV	Vertex Self Curing,Vertex Castavaria,Vertex Castapress	K102640	03/25/2011	EBI	SecondaryPredicate

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

5. Description of Device

Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.

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Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth, and its extensive indications can meet the needs of the production of complete denture.

6. Indications for use

Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.

7. Summary of Physical and Chemical Properties Tests

Chemical Composition:
The device has similar chemical composition as the predicate devices. All of them are mainly composed of Polymethyl methacrylate and Pigments (Powder) and Methyl methacrylate, Ethyleneglycol dimethacrylate (Liquid).
Technological characteristics:
The device has the same technological characteristics as the predicate devices (Heat Curing and Self Curing). And the device is similar in specifications and shades as the predicate devices.
Properties:
The device has comparable physical and chemical properties as the predicate devices.

(Meeting the requirements of ISO standards for the Dental base material, ISO 20795-1)

Applications:
The device has similar indications for use as the sum of the predicate devices: fabrication and repair of partial and full denture base.

8. Technological Characteristics:

The new device, Denture Base Polymers, has the same design, main materials and chemical composition as the predicate device.

Comparison Items	New Device	Primary Predicate	Secondary Predicate
	Denture Base Polymers	Vertex Rapid Simplified	Vertex Self Curing, Vertex Castavaria, Vertex Castapress
	K220680	K102654	K102640
1) Regulatory Classifications	same	same	same
2) Indications for use	This product is used for fabrication and repair of partial and full denture base for patients with missing teeth.	The Vertex Rapid Simplified is indicated for:1. Fabrication of full dentures2. Fabrication of partial dentures	Vertex cold-curing denture base materials are indicated for:1. Manufacture of full and partial dentures2. Repair of full and partial dentures3. Rebasing of full and partial dentures4. Relining of full and partial

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HUGE

	Comparison Items	New Device	Primary Predicate	Secondary Predicate
		Denture Base PolymersK220680	Vertex Rapid SimplifiedK102654	Vertex Self Curing, VertexCastavaria, Vertex CastapressK102640
3)	Contraindications	NA	NA	denturesNA
4)	Compositionof Materials	PMMA, MMA, EDMA	PMMA, MMA, EDMA	PMMA, MMA, EDMA
5)	PhysicalProperties	NewDevice	Physicalparameters	Flexuralstrength	Waterabsorption	Solubility	Residualmethylmethacrylatemonomer	Flexuralmodulus
				Type 1: ≥ 65 MPaType 2: ≥ 60 MPa	≤ 32 ug/mm³	Type 1: ≤ 1.6 ug/mm³Type 2: ≤ 8.0 ug/mm³	Type 1: ≤ 2.2%Type 2: ≤ 4.5%	Type 1: ≥ 2000 MPaType 2: ≥ 1500 MPa
		Type 1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1
		Type 2	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1
		Primary Predicate(K102654)Secondary Predicate(K102640)	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1	Meet the criteriaper ISO 20795-1
6)	Labeling		similar	similar		similar
7)	Target Population		dental patients	dental patients		dental patients
8)	Anatomical Site		on teeth	on teeth		on teeth
9)	Where Used		used in hospital, dental clinicand relevant places	used in hospital, dental clinicand relevant places		used in hospital, dental clinicand relevant places
10)	Human Factors		dental professional	dental professional		dental professional
11)	Design		same	same		same
12)	Cautions		similar		similar		similar
13)	Standards Met		same		same		same
14)	Biocompatibility		biocompatible	biocompatible		biocompatible
15)	Sterility		Non-sterile		Non-sterile		Non-sterile
16)	Chemical Safety		similar		similar		similar

9. Summary of Biocompatibility

The new device, Denture Base Polymers, 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.

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We selected our Denture Base Polymers (Model: Type 2 Class 1) as the representative in biocompatibility tests and those biocompatibility test reports can be used in the biological evaluation of Denture Base Polymers.

Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity; Sensitization; Irritation or Intracutaneous Reactivity; Acute Systemic Toxicity; Material-Mediated Pyrogenicity; Subchronic Toxicity; Genotoxicity and Implantation.

10. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed on 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. The details of indications for use, composition of materials, physical properties, labeling, stability/shelf life and cautions are slightly different, but the minor differences between the new device and the predicate devices are out of significance and do not affect neither the general intended use nor substantial equivalence.

We conclude that our Denture Base Polymers is substantially equivalent to the predicate devices described herein.

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.