Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a light-curable resin for fabricating dentures using a CAD/CAM system and additive printing. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and manufacturing process.

Therapeutic

No
The device is a light-curable resin used for fabricating and repairing removable denture bases and try-in dentures, which are prosthetic devices rather than therapeutic devices.

Diagnostic

No

The device, DENTCA Base Resin, is a material used for fabricating and repairing denture bases, which is a manufacturing process, not a diagnostic one. It does not identify or diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device is a light-curable resin, which is a physical material used in the fabrication of dentures. It requires an additive printer and curing light equipment, indicating it is a hardware component, not software only.

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 for the fabrication and repair of removable denture bases. This is a physical prosthesis used in the body, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is a light-curable resin used in a CAD/CAM system to create physical dentures.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance metrics are related to the physical properties of the material and the fabricated denture, not diagnostic accuracy.

IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

EBI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Fabricated by Dental professionals in a dental lab

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)

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 Dentistry – 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. Key results from the table include:

Flexural Modulus: Meet the consensus STD (for both DENTCA Base Hi-Impact and Premium)
Flexural Strength: Meet the consensus STD (for both DENTCA Base Hi-Impact and Premium)
Water Sorption: Meet the consensus STD (for both DENTCA Base Hi-Impact and Premium)
Water Solubility: Meet the consensus STD (for both DENTCA Base Hi-Impact and Premium)
Maximum Intensity Factor: Meet the consensus STD (for DENTCA Base Hi-Impact), Not claimed (for Premium)
Total Fracture Work: Meet the consensus STD (for DENTCA Base Hi-Impact), Not claimed (for Premium)
Residual Methylmethacrylate: Not Detectable (for both DENTCA Base Hi-Impact and Premium)

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190043

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K160244

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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.

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

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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 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

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Indications for Use

510(k) Number (if known) K220042

Device Name DENTCA Base Resin

Indications for Use (Describe)

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.

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)
-----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

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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

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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

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.

Indications For Use

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.

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.

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Table 5.1 Comparison of Technical Features

| | Subject Device | Predicate Device | Reference Device | Similarities and
Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Names | DENTCA Base Resin | Halley Resin | DENTCA Denture
Base II | NA |
| Regulation &
Product Code | 872.3760; EBI | 872.3760; EBI | 872.3760; EBI | Same Classification |
| Intended Use | Fabrication and repair of
removable denture bases
and dental appliances | Fabrication and repair of
removable denture bases
and dental appliances. | Fabrication and repair of
removable denture bases
and dental prosthesis | Same Intended Use |
| Indications For
Use | 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. | Halley resin is a light-
cured resin indicated for
the fabrication of denture
bases in dental
laboratories, including full
and partial dentures as well
as implant overdentures,
and other dental
appliances. Halley resin
can be used as a try-in
material for evaluation
prior to fabrication of the
final restoration.
Fabrication of these
prostheses require a | DENTCA Denture Base
II is a light-curable resin
indicated for fabrication
and repair of full and
partial removable
dentures and baseplates.
The material is an
alternative to traditional
heat-curable and auto
polymerizing resins.
Fabrication of dental
prosthetics with
DENTCA Denture Base
II requires a computer-
aided design and
manufacturing | All three devices
are light-cure resins
indicated for
fabrication and
repair of dental
prostheses. |
| 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. | computer-aided design and
manufacturing
(CAD/CAM) system using
an additive printer.
Halley resin can be utilized
as an aid in bonding
denture base to denture
teeth as well as repair using
traditional techniques. | (CAD/CAM) system
that includes the
following components:
digital denture base files
based on a digital
impression,
stereolithographic
additive printer, and
curing light equipment. | | |

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Device Description

Resin Type	Type 4, Light-cure resin	Type 4, Light-cure resin	Type 4, Light-cure resin	Same Technology
Chemical
Composition	Acrylate-based resins with
photoinitiator, and pigments	Acrylate-based resins with
photoinitiator, and
pigments	Acrylate-based resins
with photoinitiator, and
pigments	Same Technology
Fabrication
Method of
Denture Base	Automated 3D printing of
resin in multiple layers, and
post-curing in light curing
unit	Automated 3D printing of
resin in multiple layers,
and post-curing in light
curing unit	Automated 3D printing
of resin in multiple
layers, and post-curing
in light curing unit	Same Technology
Teeth Assemble	Chemical Bonding	Chemical Bonding	Chemical Bonding	Same Technology
Requirement	Meets the specification of
ISO 20795-1 for Type 4
material	Meets the specification of
ISO 20795-1 for Type 4
material	Meets the specification
of ISO 20795-1 for
Type 4 material	Same Standard
Intended User	Fabricated by Dental
professionals in a dental lab	Fabricated by Dental
professionals in a dental
lab	Fabricated by Dental
professionals in a dental
lab	Same User

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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.

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| Representative
Physical Properties | ISO 20795-1 | Subject Device | | Predicate
Device | Reference
Device |
|---------------------------------------|-------------------------------------|------------------------------|------------------------------|------------------------------|------------------------------|
| | Specification
of Type 4
resin | DENTCA Base
Hi-Impact | Premium | Halley
Resin* | DENTCA
Denture
Base II |
| Flexural Modulus | ≥ 2000 MPa | Meet the
consensus
STD | Meet the
consensus
STD | Meet the
consensus
STD | Meet the
consensus
STD |
| Flexural Strength | ≥ 65 MPa | Meet the
consensus
STD | Meet the
consensus
STD | Meet the
consensus
STD | Meet the
consensus
STD |
| Water Sorption |