The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Denture Base Resin." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or safety through new clinical trials. Therefore, the information typically requested in your prompt regarding AI/ML device performance (e.g., acceptance criteria for a specific AI metric, human-in-the-loop performance, large test sets, expert ground truth adjudication) is not applicable to this submission.

This document describes a traditional dental material. The performance data presented are for material properties, not an AI/ML algorithm.

Here's why many of your detailed questions cannot be answered by this document:

AI/ML Device: This is not an AI/ML device. It's a physical material used for fabricating dentures.
Acceptance Criteria for AI Performance: The acceptance criteria are for physical material properties as defined by ISO standards, not for AI metrics like sensitivity, specificity, AUC, or F1-score.
Sample Size for Test Set (AI): There's no AI test set. Instead, there are samples of the material tested for its physical and chemical properties.
Data Provenance (AI): Not applicable. The "data" are laboratory measurements of material properties.
Experts for Ground Truth (AI): Not applicable. Ground truth for material properties is established through standardized laboratory testing methods.
Adjudication Method (AI): Not applicable.
MRMC Study (AI): Not applicable. This refers to human reader performance with/without AI assistance for diagnostic tasks, which is irrelevant here.
Standalone Performance (AI): Not applicable.
Type of Ground Truth (AI): For this device, "ground truth" refers to the measured physical and chemical properties of the material against established standards (e.g., ISO, FDA guidance).
Training Set (AI): Not applicable. This device is not developed using machine learning.
Ground Truth for Training Set (AI): Not applicable.

Based on the provided document, here's what can be extracted regarding the "acceptance criteria" (which are performance specifications for the material) and its "study" (which are non-clinical bench tests):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the relevant ISO standards (ISO20795-1: 2013, ISO 4049: 2019, ISO 7491: 2000) and the comparison to the predicate device. The performance data demonstrate compliance with these standards and substantial equivalence.

Item	Acceptance Criterion (Implicit: Meet relevant ISO standards and be similar to predicate)	Reported Device Performance (Denture Base Resin)	Predicate Device Performance (IvoBase CAD for Zenotec)
Ultimate flexural strength	> Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	87 Mpa	82 Mpa
Flexural modulus	> Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	2340 Mpa	2032 Mpa
Residual methyl methacrylate monomer	≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	1.29%	1.34%
Sorption	≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	23.64 µg/mm³	19.48 µg/mm³
Solubility	≤ Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	0.25 µg/mm³	0.65 µg/mm³
Maximum stress intensity factor for materials with improved impact resistance	> Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	2.89 MPa m¹ᐟ²	2.35 MPa m¹ᐟ²
Total fracture work	> Predicate's Performance (or within acceptable range to prove SE) and meet ISO standards	1609 J/m²	1411 J/m²
Biocompatibility	Pass all required biocompatibility tests (ISO 10993-1) for surface device, permanent contact (>30 d) with mucosal membrane	Passed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subchronic systemic toxicity, Implantation, Material-mediated pyrogenicity, Genotoxicity)	Passed (Assessed as equivalent)
Other Performance Bench Tests	Meet all design specifications and relevant ISO standards (Surface characteristics, Shape capability, Colour, Colour stability, Translucency, Freedom from porosity, Bonding to synthetic polymer teeth)	Complies with ISO standards	Complies with ISO standards

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes for each bench test conducted (e.g., how many specimens for flexural strength). It generally states that "Performance testing were conducted to verify that the subject device met all design specifications." Specific sample sizes would be detailed in the full test reports, which are not part of this summary.
Data Provenance: The tests are non-clinical bench tests performed in a laboratory setting, presumably by the manufacturer (Aidite (Qinhuangdao) Technology Co., Ltd) or a contracted lab. The country of origin for the data is implicitly China, as the manufacturer is based there. The data are retrospective in the sense that they were collected prior to the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for material properties is established through standardized and validated laboratory testing procedures as per ISO standards.

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

Not applicable. This concept applies to human reader studies often seen with diagnostic AI/ML devices, not material property testing.

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:

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device.

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

No, a standalone algorithm performance study was not done. 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's performance is derived from standardized laboratory measurement methods as described in the cited ISO standards (e.g., ISO20795-1 for denture base polymers, ISO 4049 for polymer-based restorative materials, ISO 7491 for color stability) and biocompatibility testing according to ISO 10993-1. Comparison is also made to the performance characteristics of the predicate device.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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 & 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.

March 17, 2023

Aidite (Qinhuangdao) Technology Co., Ltd % Julie Chen Consultant ICAS Group 155 Pingbei Rd, Minghang Shanghai, Shanghai 201100 CHINA

Re: K230115

Trade/Device Name: Denture Base Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 13, 2023 Received: January 17, 2023

Dear Julie Chen:

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

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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 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 -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K230115

Device Name

Denture Base Resin

Indications for Use (Describe)

Denture Base Resin is used for the fabrication of removable dentures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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510(K) Summary K230115

I. SUBMITTER:

Aidite (Oinhuangdao) Technology Co., Ltd No.9 Dushan Road, Economic and Technological Development Zone,Qinhuangdao City China Contact Person: Chen Yingying Title: Registered Engineer Tel: 15033560085 Email: chenyingying@aidite.com

Submission Correspondent: Julie Chen Email: cl.julie@hotmail.com Tel:+86 139 1804 5781

Summary prepared: 03/16/2023

II. DEVICE

Name of Device: Denture Base Resin Trade Name: Denture Base Resin Common Name: Denture Relining, Repairing, or Rebasing Resin Regulation Number: 21 CFR PART 872.3690 Classification Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI

III. PREDICATE DEVICE

Primary predicate device: K151142(IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid)

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IV. DEVICE DESCRIPTION

V. AVAIABLE MODEL

Model	Shade	Specification
FDB-LC	A1P1、A2P1、A3P1、A3.5P1、A4P1、B1P1、B2P1、C1P1、C2P1、OM1P1、BL3P1、A1P2、A2P2、A3P2、A3.5P2、A4P2、B1P2、B2P2、C1P2、C2P2、OM1P2、BL3P2、A1P3、A2P3、A3P3、A3.5P3、A4P3、B1P3、B2P3、C1P3、C2P3、OM1P3、BL3P3、A1P4、A2P4、A3P4、A3.5P4、A4P4、B1P4、B2P4、C1P4、C2P4、OM1P4、BL3P4、A1P5、A2P5、A3P5、A3.5P5、A4P5、B1P5、B2P5、C1P5、C2P5、OM1P5、BL3P5、A1P6、A2P6、A3P6、A3.5P6、A4P6、B1P6、B2P6、C1P6、C2P6、OM1P6、BL3P6	Disc shape: 95×20、95×25、95×30、95×35、95×38、95×40、98×20、98×25、98×30、98×35、98×38、98×40 (Unit: mm)Horseshoe: 101×20、101×25、101×30、101×35、101×38、101×40 (Unit: mm)
	FDB-LM	B3P2、B3P4、B3P5、B4P2、B4P4、B4P5、C3P2、C3P4、C3P5、C4P2、C4P4、C4P5、D2P2、D2P4、D2P5、D3P2、D3P4、D3P5、D4P2、D4P4、D4P5、OM2P2、OM2P4、OM2P5、OM3P2、OM3P4、OM3P5、BL1P2、BL1P4、BL1P5、BL2P2、BL2P4、BL2P5、BL4P2、BL4P4、BL4P5
		A1P1、A2P1、A3P1、A3.5P1、A4P1、B1P1、B2P1、C1P1、C2P1、OM1P1、BL3P1、A1P2、A2P2、A3P2、A3.5P2、A4P2、B1P2、B2P2、C1P2、C2P2、OM1P2、BL3P2、A1P3、A2P3、A3P3、A3.5P3、A4P3、B1P3、
	B2P3、C1P3、C2P3、OM1P3、BL3P3、A1P4、A2P4、A3P4、A3.5P4、A4P4、B1P4、B2P4、C1P4、C2P4、OM1P4、BL3P4、A1P5、A2P5、A3P5、A3.5P5、A4P5、B1P5、B2P5、C1P5、C2P5、OM1P5、BL3P5、A1P6、A2P6、A3P6、A3.5P6、A4P6、B1P6、B2P6、C1P6、C2P6、OM1P6、BL3P6	101×40 (Unit: mm)
	B3P2、B3P4、B3P5、B4P2、B4P4、B4P5、C3P2、C3P4、C3P5、C4P2、C4P4、C4P5、D2P2、D2P4、D2P5、D3P2、D3P4、D3P5、D4P2、D4P4、D4P5、OM2P2、OM2P4、OM2P5、OM3P2、OM3P4、OM3P5、BL1P2、BL1P4、BL1P5、BL2P2、BL2P4、BL2P5、BL4P2、BL4P4、BL4P5	Disc shape: 98×30、98×35、98×38 (Unit: mm)
	A1P1、A2P1、A3P1、A3.5P1、A4P1、B1P1、B2P1、C1P1、C2P1、OM1P1、BL3P1、A1P2、A2P2、A3P2、A3.5P2、A4P2、B1P2、B2P2、C1P2、C2P2、OM1P2、BL3P2、A1P3、A2P3、A3P3、A3.5P3、A4P3、B1P3、B2P3、C1P3、C2P3、OM1P3、BL3P3、A1P4、A2P4、A3P4、A3.5P4、A4P4、B1P4、B2P4、C1P4、C2P4、OM1P4、BL3P4、A1P5、A2P5、A3P5、A3.5P5、A4P5、B1P5、B2P5、C1P5、C2P5、OM1P5、BL3P5、A1P6、A2P6、A3P6、A3.5P6、A4P6、B1P6、B2P6、C1P6、C2P6、OM1P6、BL3P6	Notched Disc: 98×20、98×25、98×30、98×35、98×38、98×40(Unit: mm)
FDB-CC	B2P5、C1P5、C2P5、OM1P5、BL3P5、A1P6、A2P6、A3P6、A3.5P6、A4P6、B1P6、B2P6、C1P6、C2P6、OM1P6、BL3P6
	B3P2、B3P4、B3P5、B4P2、B4P4、B4P5、C3P2、C3P4、C3P5、C4P2、C4P4、C4P5、D2P2、D2P4、D2P5、D3P2、D3P4、D3P5、D4P2、D4P4、D4P5、OM2P2、OM2P4、OM2P5、OM3P2、OM3P4、OM3P5、BL1P2、BL1P4、BL1P5、BL2P2、BL2P4、BL2P5、BL4P2、BL4P4、BL4P5
	Notched Disc: 98×30、98×35、98×38 (Unit: mm)
FDB-CM	A1P1、A2P1、A3P1、A3.5P1、A4P1	Notched Disc: 98×20、98×25、

	B1P1、B2P1、C1P1、C2P1、OM1P1、98×30、98×35、98×38、98×40BL3P1、 A1P2、 A2P2 、 A3P2 、(Unit: mm)
	A3.5P2、A4P2、B1P2、B2P2、C1P2、
	C2P2、OM1P2、BL3P2、A1P3、
	A2P3、A3P3、A3.5P3、A4P3、B1P3、
	B2P3 、 C1P3 、 C2P3 、 OM1P3 、
	BL3P3、 A1P4、 A2P4、 A3P4、
	A3.5P4、A4P4、B1P4、B2P4、C1P4、
	C2P4、OM1P4、BL3P4、A1P5、
	A2P5、A3P5、A3.5P5、A4P5、B1P5、
	B2P5、C1P5、C2P5、OM1P5、
	BL3P5、 A1P6、 A2P6、 A3P6、
	A3.5P6、A4P6、B1P6、B2P6、C1P6、
	C2P6、OM1P6、BL3P6
	B3P2、B3P4、B3P5、B4P2、B4P4、
	B4P5、C3P2、C3P4、C3P5、C4P2、
	C4P4、C4P5、D2P2、D2P4、D2P5、
	D3P2、D3P4、D3P5、D4P2、D4P4、Notched Disc: 98×30、98×35、
	D4P5、OM2P2、OM2P4、OM2P5、98×38 (Unit: mm)
	OM3P2、OM3P4、OM3P5、BL1P2、
	BL1P4、BL1P5、BL2P2、BL2P4、
	BL2P5、BL4P2、BL4P4、BL4P5
	Disc shape: 98×20、98×22、
	98×25、98×28、98×30、98×35、
	98×38、98×40、95×20、95×22、
	95×25、95×28、95×30、95×35、
FDB-C	P1、P2、P3、P4、P5、P695×38、95×40 (Unit: mm)
	Horseshoe: 101×20、101×22、
	101×25、101×28、101×30、
	101×35 、 101×38 、 101×40(Unit: mm)

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VI. INTENED USE per 21CFR 807.92(A)(5)

Denture Base Resin is used for the fabrication of removable dentures.

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INDICATIONS for USE per Form FDA 3881 VII.

Denture Base Resin is used for the fabrication of removable dentures.

VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Denture Base Resin are compared with the predicate device, IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142). The results are shown below in the Technological Characteristics Comparison Table:

Item	Subject Device	Predicate Device	Remark
	Denture BaseResin	IvoBase CAD forZenotec andIvoBase CAD Bondand ModellingLiquid
510(k) number	K230115	K151142	--
Regulation Number	21 CFR PART 872.3690	21 CFR PART 872.3690	SE
Product Code	EBI	EBI	SE
Common name	Denture Relining, Repairing,or Rebasing Resin	Denture Relining, Repairing, orRebasing Resin	SE
Classification	II	II	SE
Manufacturer	Aidite(Qinhuangdao)Technology Co., Ltd	Ivoclar Vivadent, Incorporated	--
Intended Use	Denture Base Resin is used forthe fabrication of removabledentures.	IvoBase CAD for Zenotec, IvoBaseCAD Bond and Modelling Liquidis a system used:For the fabrication of removabledentures,e.g.:partial and completedenture prosthetics hybrid denture prosthetics combined dentureprosthetics mouthguards implant-supported dentureprosthetics	SE
Type Use	Prescription (Rx Only)	Prescription (Rx Only)	SE
CAD CAM Technology	Denture Base Resin isintended for use in thefabrication of dentureprosthetics using CAD CAMTechnology.	IvoBase CAD for Zenotec is aPMMA disc intended for use inthe fabrication of dentureprosthetics using CAD CAMTechnology.	SE
Monomer/polymer form	The resin block is formedusing CAD CAM technology.The product combines theprosthetic denture teeth withthe denture base.	The denture base is formed usingCAD CAM technology. Theprosthetic denture teeth are thenbonded to the denture base usingIvoBase CAD Bond and IvoBaseCAD Modelling Liquid. IvoBaseCAD Bond consists of a powderpolymer and monomer liquidsimilar to a traditional denturebase device.	Similar
Principle of operation	Step-by-step:- Design andprocessing ofCAD/CAMremovable dentures- SeparateAfter CAD/CAMcutting, therestoration isseparated from theresin block with atungsten carbide ordiamond bur.- Polishing- Cleaning anddisinfection- Insertion	Step-by-step:- Anatomical impressionand pre- bite registration- Lab makes scan ofimpression and millsindividual tray- Functional impressionand bite registration- Lab makes scan andmills try-in body (TrayDisc for Zenotec)- Try-in and esthetic,functional check- Lab makes finaldenture. IvoBase CADfor Zenotec can beprocessed using theZenotec select millingmachine. First the lingualside is milled, then theteeth are bonded inposition using ivoBaseCAD Bond and then thebasal side is milled.- After milling, thedenture base is separatedfrom the disc, shape	SE
		adjustments are made andthen it is polished.• Insertion
Composition	The Denture Base Resin mainlyconsist of denture base resin(powder), polymethylmethacrylate (PMMA), methylmethacrylate, ethylene glycoldimethacrylate, titaniumdioxide, ferric oxide, iron oxideyellow and ferric tetroxide.	The chemical composition of thenew product and predicate are thesame, except for small changes inpigments and the fact that the discproduct is industriallypolymerized. Therefore certainingredients (the methylmethacrylate and initiators) areno longer present. The result ofthe biocompatibility assessmentis that the product is equivalent tothe predicate.	Similar
Biocompatibility	Biocompatibility in accordanceto 10993-1(Surface device incontact with mucosal membranewith permanent contact (>30 d))	Biocompatibility in accordanceto 10993-1(Surface device in contactwith mucosal membrane withpermanent contact (>30 d))	Same
Performance	Ultimate flexural strength 87Mpa;Flexural modulus 2340Mpa;Residual methyl methacrylatemonomer 1.29%Sorption 23.64 µg/mm3Solubility 0.25 µg/mm3Maximum stress intensityfactor for materials withimproved impact resistance2.89MPa m1/2Total fracture work 1609 J/m2	Ultimate flexural strength82 Mpa;Flexural modulus 2032Mpa;Residual methyl methacrylatemonomer1.34%Sorption 19.48 µg/mm3Solubility 0.65 µg/mm3Maximum stress intensity factorfor materials with improvedimpact resistance2.35 MPa m1/2Total fracture work 1411 J/m2	Similar

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IX. SUBSTANTIAL EQUIVALENCE DISCUSSION per 21 CFR 807.92(b)

Denture Base Resin has been conducted biocompatibility studies in accordance with ISO 10993 to demonstrate the device is as safe as its predicate device. The performance bench testing was conducted to demonstrate that the subject device is as effective as its predicate device.

X. PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Biocompatibility

Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of

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International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with Surface device in contact with mucosal membrane with permanent contact (>30 d). The subject device was evaluated for: Cytotoxicity Sensitization

Irritation Acute systemic toxicity Subchronic systemic toxicity Implantation Material-mediated pyrogenicity Genotoxicitv

Performance Bench Testing

Performance testing were conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Dental Base Resin complies with the following standards:

. ISO20795-1: 2013 Dentistry—Base polymers —Part 1:Denture base polymers
ISO 4049: 2019 Dentistry Polymer-based restorative materials; ●
ISO 7491: 2000 Dental materials-Determination of color stability. ●

The subject device and predicate device were evaluated for:

1)Surface characteristics:

2)Shape capability;

3)Colour;

4)Colour stability;

5)Translucency:

6)Freedom from porosity;
7)Ultimate flexural strength;

8)Flexural modulus;

9)Bonding to synthetic polymer teeth

10)Residual methyl methacrylate monomer

11)Sorption and solubility

Maximum stress intensity factor for materials with improved impact resistance and total fracture work

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Clinical Test Conclusion

No clinical study is included in this submission.

XI. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142).

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.