DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

Device Description

DENTCA Base Resin is a light-curable resin intended to fabricate removable dentures in a CAD/CAM system using an additive printing process. This material is used as an alternative to traditional heat cured and auto polymerizing denture base resins and is available in multiple shades. DENTCA Base Resin can also be utilized to repair the printed denture and to bond printed teeth onto denture base.

AI/ML Overview

The provided text does not contain information about an AI/ML powered device, but rather a dental resin material. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets these criteria for an AI/ML device.

The document is a 510(k) premarket notification for a dental resin called "DENTCA Base Resin," which is a light-curable resin for fabricating and repairing removable denture bases. The "Performance Data" section discusses:

Biocompatibility Testing: Conducted according to ISO 7405:2018 and FDA Guidance for medical devices in dentistry.
Software Verification and Validation Testing: For the additive printing (3D printer) operation software, in accordance with FDA guidance for "Off-The-Shelf Software Use in Medical Devices" and "Technical Considerations for Additive Manufactured Medical Devices."
Performance Bench Test: Conducted according to ISO 20795-1:2013, which specifies requirements for denture base polymers.

The table 5.2 "Comparison of Performance Bench Test" shows the acceptance criteria (specifications of Type 4 resin) and the reported performance of the subject device (DENTCA Base Hi-Impact and Premium), the predicate device (Halley Resin), and a reference device (DENTCA Denture Base II). All listed devices "Meet the consensus STD" or are "Not Detectable" for Residual Methylmethacrylate, indicating they meet the specified physical properties.

This document describes the testing for a physical material, not an AI/ML algorithm. Therefore, the requested details about multi-reader multi-case studies, ground truth establishment for AI, sample sizes for training sets, or expert qualifications are not applicable and not present in the provided text.

Summary

{0}------------------------------------------------

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.

November 17, 2022

Dentca, Inc. Jason Lee Principal Scientist 357 Van Ness Way, Ste 250 Torrance, California 90501

Re: K220042

Trade/Device Name: Dentca Base Premium, Dentca Base Hi-Impact Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: October 18, 2022 Received: October 19, 2022

Dear Jason Lee:

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

{1}------------------------------------------------

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 medical devices and radiation-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220042

Device Name DENTCA Base Resin

Indications for Use (Describe)

Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment.

DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

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."

{3}------------------------------------------------

510(k) Summary - K220042

Submitter

DENTCA, INC. 357 Van Ness Way, Suite 250 Torrance, CA 90501

Phone: 424-558-8726 Fax: 424-558-8738 Contact Person: Jason Lee Date Prepared: December 3, 2021 Date Revised: October 14, 2022

Device Classification

Proprietary Name:	DENTCA Base Resin
Trade Name:	DENTCA Base Premium, DENTCA Base Hi-Impac
Common Name:	Dental Acrylic Resin
Classification Name:	Denture relining, repairing, or rebasing resin
Regulation Number:	21 CFR 872.3760
Product Code:	EBI
Regulatory Class:	II
Review Panel:	Dental

Predicate Device

The following predicate is a legally marketed, post-amendment device:

510(k) Number:	K190043
Clearance Date:	April 24, 2019
Trade Name:	Halley Resin
Actual Trade Name:	Lucitone Digital Print
Manufacturer:	Dentsply Sirona
Regulation Number:	21 CFR 872.3760
Product Code:	EBI

{4}------------------------------------------------

Reference Device

The following reference is a legally marketed, post-amendment device:

510(k) Number:	K160244
Clearance Date:	March 3, 2017
Actual Trade Name:	DENTCA Denture Base II
Manufacturer:	DENTCA, Inc.
Regulation Number:	21 CFR 872.3760
Product Code:	EBI

Device Description

Indications For Use

DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

Both the subject and predicate are light-curable resins indicated for fabrication and repair of dental prostheses.

Comparison of Technological Characteristics With Predicate

The following table compares technological and other characteristics of the subject, predicate, and reference devices.

{5}------------------------------------------------

Table 5.1 Comparison of Technical Features

	Subject Device	Predicate Device	Reference Device	Similarities andDifferences
Device Names	DENTCA Base Resin	Halley Resin	DENTCA DentureBase II	NA
Regulation &Product Code	872.3760; EBI	872.3760; EBI	872.3760; EBI	Same Classification
Intended Use	Fabrication and repair ofremovable denture basesand dental appliances	Fabrication and repair ofremovable denture basesand dental appliances.	Fabrication and repair ofremovable denture basesand dental prosthesis	Same Intended Use
Indications ForUse	DENTCA Base Resin is alight-curable resin indicatedfor the fabrication andrepair of removable denturebases in dental laboratories,including full and partialdentures as well asimmediate dentures, andbaseplates. DENTCA BaseResin can also be used forthe fabrication of try-indentures for the evaluationbefore fabricating the finaldentures.	Halley resin is a light-cured resin indicated forthe fabrication of denturebases in dentallaboratories, including fulland partial dentures as wellas implant overdentures,and other dentalappliances. Halley resincan be used as a try-inmaterial for evaluationprior to fabrication of thefinal restoration.Fabrication of theseprostheses require a	DENTCA Denture BaseII is a light-curable resinindicated for fabricationand repair of full andpartial removabledentures and baseplates.The material is analternative to traditionalheat-curable and autopolymerizing resins.Fabrication of dentalprosthetics withDENTCA Denture BaseII requires a computer-aided design andmanufacturing	All three devicesare light-cure resinsindicated forfabrication andrepair of dentalprostheses.
Fabrication ofthese prostheses withDENTCA Base Resinrequires a digital denturefile, additive printer, andcuring light equipment.DENTCA Base Resin canbe utilized as an aid inbonding the denture teethonto denture base.	computer-aided design andmanufacturing(CAD/CAM) system usingan additive printer.Halley resin can be utilizedas an aid in bondingdenture base to dentureteeth as well as repair usingtraditional techniques.	(CAD/CAM) systemthat includes thefollowing components:digital denture base filesbased on a digitalimpression,stereolithographicadditive printer, andcuring light equipment.

{6}------------------------------------------------

Device Description

Resin Type	Type 4, Light-cure resin	Type 4, Light-cure resin	Type 4, Light-cure resin	Same Technology
ChemicalComposition	Acrylate-based resins withphotoinitiator, and pigments	Acrylate-based resins withphotoinitiator, andpigments	Acrylate-based resinswith photoinitiator, andpigments	Same Technology
FabricationMethod ofDenture Base	Automated 3D printing ofresin in multiple layers, andpost-curing in light curingunit	Automated 3D printing ofresin in multiple layers,and post-curing in lightcuring unit	Automated 3D printingof resin in multiplelayers, and post-curingin light curing unit	Same Technology
Teeth Assemble	Chemical Bonding	Chemical Bonding	Chemical Bonding	Same Technology
Requirement	Meets the specification ofISO 20795-1 for Type 4material	Meets the specification ofISO 20795-1 for Type 4material	Meets the specificationof ISO 20795-1 forType 4 material	Same Standard
Intended User	Fabricated by Dentalprofessionals in a dental lab	Fabricated by Dentalprofessionals in a dentallab	Fabricated by Dentalprofessionals in a dentallab	Same User

{7}------------------------------------------------

The above comparison shows the similarities on indications for use and technological aspects among the devices. A comparison proved that all devices fabricate the denture bases and dental prosthesis in the same manner, via automated application of a light-cure resins in an additive 3D printer.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for DENTCA Base Resin was conducted in accordance with the standard ISO 7405:2018 Dentistrv – Evaluation of biocompatibility of medical devices used in dentistry and the FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."

The denture base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).

Software Verification and Validation Testing

The operation software for additive printing (3D printer) was verified and validated in accordance with the FDA guidance "FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices" and "Technical Considerations for Additive Manufactured Medical Devices."

Performance Bench Test

Bench test for DENTCA Base Resin was conducted in accordance with ISO 20795-1:2013, as recognized by FDA. The data support a conclusion that the subject device meets the requirements per ISO 207495-1 standard as presented in Table 5.2 below.

{8}------------------------------------------------

RepresentativePhysical Properties	ISO 20795-1	Subject Device		PredicateDevice	ReferenceDevice
	Specificationof Type 4resin	DENTCA BaseHi-Impact	Premium	HalleyResin*	DENTCADentureBase II
Flexural Modulus	≥ 2000 MPa	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD
Flexural Strength	≥ 65 MPa	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD
Water Sorption	< 32 µg/mm³	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD
Water Solubility	< 1.6 µg/mm³	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD	Meet theconsensusSTD
Maximum IntensityFactor	≥ 1.9 MPam1/2	Meet theconsensusSTD	Notclaimed	Meet theconsensusSTD	Notclaimed
Total Fracture Work	≥ 900 J/m²	Meet theconsensusSTD	Notclaimed	Meet theconsensusSTD	Notclaimed
ResidualMethylmethacrylate	< 2.2%	NotDetectable	NotDetectable	Meet theconsensusSTD	NotDetectable

Table 5.2 Comparison of Performance Bench Test

Data cited from the predicate device K190043 510(k) Summary, Table 5.2

Conclusions

The above comparison of the subject and predicate devices shows that both devices fabricate the denture in the same manner, via automated application of a light-curable resin in an additive 3D printer.

{9}------------------------------------------------

The subject and predicate devices have the same intended use, similar indications for use, and comprise the same technological characteristics.

Furthermore, the non-clinical data support the safety and effectiveness of the device and demonstrates that DENTCA Base Resin should perform as intended in the specified use conditions.

In conclusion, DENTCA Base Resin is substantially equivalent to the legally marketed Halley Resin, and thus warrants clearance from FDA for premarketing activities in the United States.

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.