Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.

Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.

Device Description

Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.

The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12.

The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.

AI/ML Overview

The provided text describes a submission for a dental device, "Dentca Denture Base," for FDA 510(k) clearance. This device is a photosensitive resin used in a CAD/CAM additive printing process to fabricate removable dentures. The key aspect of the submission, from a performance data perspective, is demonstrating that the new manufacturing method (3D printing) yields a product that is substantially equivalent to existing, manually fabricated denture bases.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Dentca Denture Base" are primarily based on established industry consensus standards for dental materials, specifically ISO 20795-1 (Dentistry - Base polymers - Part 1: Denture base polymers). While the document doesn't explicitly list "acceptance criteria" in a go/no-go format, it presents key performance specifications derived from this standard that the device was tested against.

Acceptance Criterion (Implicit based on ISO 20795-1)	Reported Device Performance
Flexural strength	90.2 MPa
Flexural modulus	2,290 MPa
Residual monomer	Not detectable
Water sorption	14 ug/mm3
Water solubility	1.3 ug/mm3
Biocompatibility (Genotoxicity, Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Material Characterization)	Conformed to FDA Blue Book Memorandum #G95-1 and ISO 10993-1 (Pass)

Note: The document states "Dentca Denture Base was tested for conformity with the industry consensus standard ISO 20795-1," implying that the reported values meet or exceed the requirements of this standard for these properties.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the bench testing (flexural strength, modulus, water sorption, water solubility, residual monomer). It only mentions that these tests were conducted.

Regarding data provenance:

The data is generated from bench testing of the Dentca Denture Base material.
The origin of the data (country, specific lab) is not specified, but the applicant (Dentca, Inc.) is based in Los Angeles, CA, USA.
The testing is inherently prospective as it involves manufacturing and testing samples of the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission is for a material (denture base resin), not an imaging or diagnostic device requiring expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a concensus fashion (like for medical image analysis) is not applicable here. The ground truth for the material properties is established by the standardized measurement methods outlined in ISO 20795-1.

4. Adjudication Method for the Test Set

As this is bench testing of material properties against a standard, there is no adjudication method in the traditional sense (e.g., 2+1, 3+1). The "results" are quantitative measurements (e.g., 90.2 MPa for flexural strength) obtained through standardized laboratory procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or classification AI devices where human performance with and without AI assistance is being evaluated. This submission is for a dental material and its manufacturing process, not a diagnostic tool.

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

This question is not directly applicable as the device is a material, not a software algorithm. However, the performance metrics (flexural strength, modulus, etc.) are essentially "standalone" measurements of the material's physical properties. The device itself (the resin) performs its function (forming a denture base) independently of human "performance" in the analytical sense.

7. The Type of Ground Truth Used

The ground truth for the performance of the Dentca Denture Base is based on standardized, objective physical and chemical measurements as defined by ISO 20795-1. For biocompatibility, the ground truth is adherence to established biological safety standards (ISO 10993-1). This is not "expert concensus," "pathology," or "outcomes data" in the typical clinical study context for diagnostic devices.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI models. This submission is for a physical material, not an AI model that learns from data. Therefore, there is no training set in this context. The manufacturing process is based on controlled chemical formulations and physical processes.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" for this material, this question is not applicable. The "ground truth" for the material's properties is derived from the scientific principles and established testing methodologies outlined in the ISO standards, ensuring the material meets the necessary performance and safety criteria for its intended use.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2015

Dentca. Inc. c/o Mr. Claude Berthoin Denterprise International, Inc. 110 East Granada Blvd. Suite 207 Ormond Beach, Florida 32176

Re: K143033

Trade/Device Name: Dentca Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 15, 2015 Received: June 18, 2015

Dear Mr. Berthoin.

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143033

Device Name

Dentca Denture Base

Indications for Use (Describe)

Dentca Denture Base is a light-cured resin indication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.

Fabrication of dental prosthetics with Denture Base requires a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.

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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K143033 510(k) Summary

Submitter

Dentca, Inc. 3608 Griffith Avenue Los Angeles, CA 90011

Phone: 323-232-7505 Fax: 323-232-7504

Contact Person: Jason Lee Date Prepared: July 20, 2015

Consultant

Denterprise International, Inc. 110 East Granada Blvd., Suite 207 Ormond Beach, FL 32176

Phone: 386-672-0450 eFax: 855-235-7902

Contact Person: Claude Berthoin, President

Device Classification

Trade Name: Dentca Denture Base Common Name: Dental Acrylic Resin Regulation Number: 21 CFR 872.3760 Denture relining, repairing, or rebasing resin Regulation Name: Product Code: EBI Submission Type: 510(k) Regulatory Class: 2 Medical Specialty: Dental

Primary Predicate Device

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

510(k) Number:	K032892
Clearance Date:	September 26, 2003
510(k) Trade Name:	Trubyte Denture Base Resin System
Actual trade names:	Trubyte Triad VLC (Visible Light Cure) Denture Base System;Trubyte Eclipse VLC Denture Base System
Manufacturer:	Dentsply International, Inc. (York, PA, USA)
Regulation & PC:	872.3760; EBI

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Reference Device

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

510(k) Number:	K102776
Clearance Date:	February 18, 2011
510(k) Trade Name:	e-Dent Temporary Resin and Extraoral Curing System
Actual Trade Name:	EnvisionTEC E-Dent 100
Manufacturer:	DentaMed GmbH (Friedberg, Germany)
Regulation & PC:	872.3770; EBG

Device Description

Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.

Key performance specifications include:

Flexural strength...	90.2 MPa
Flexural modulus...	2,290 MPa
Residual monomer...	Not detectable
Water sorption...	14 ug/mm3
Water solubility...	1.3 ug/mm3

Indications For Use

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

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Comparison Of Technological Characteristics With Predicate

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

	K143033Subject Device	K032892Predicate Device	Differences
Device Names	Dentca Denture Base	Dentsply TrubyteDenture Base ResinSystem	NA
Classification &Product Code	872.3760; EBI	872.3760; EBI	SAME CLASSIFICATION
Intended Use	Fabrication and repair ofremovable dentures,appliances and prostheses	Fabrication and repair ofremovable dentures,appliances and prostheses	SAME INTENDED USE
Indication For Use	Dentca Denture Base is a light-cure resin indicated forfabrication and repair of full andpartial removable dentures andbaseplates. The material is analternative to traditional heat-curedand auto-polymerizing resins... The device requires aCAD/CAM system that includesthe following components notpart of the device: oral castingimpression, digital denture basefile created in an opticalimpression system, stereolithographic additive printer, andcuring light equipment.	Trubyte Denture Base ResinSystem is [a light-cure resin]indicated for fabrication andrepair of dentures,appliances and prostheses,and for relining of denturesurfaces.	BOTH DEVICES ARELIGHT-CURE RESINSINDICATED FORFABRICATION ANDREPAIR OF REMOVABLEDENTAL PROSTHESES.
Device Description
Acrylic Resin	Light-cure resin	Light-cure resin	SAME TECHNOLOGY
ChemicalCharacterization	Methacrylate-based resinswith photoinitiator, inhibitorand pigments	Methacrylate-based resinswith photoinitiator, inhibitorand pigments	SAME TECHNOLOGY
Polymerization(Curing) Method	Visible light	Visible light	SAME TECHNOLOGY
Product State	Pre-mixed resin	Pre-mixed resin	SAME TECHNOLOGY
Fabrication ofDenture Base	Automated 3D printing of resinin multiple layers, each light-curedbefore adding nextlayer, with post curing in lightchamber	Manual application of resinin multiple layers, each light-curedbefore adding nextlayer, with post curing inlight chamber	Manual vs. automatedapplication technology
Post Curing	Visible light-curing unit	Visible light-curing unit	SAME TECHNOLOGY
Teeth Assemble	Bonding	Bonding	SAME TECHNOLOGY

Table 5 -- Comparison Of Technical Features

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The above comparison shows the only technological difference between the denture polymers is method of resin application to fabricate the denture base, with the subject applied in an automated optical method and the predicate in a manual mechanical process.

A comparison of the subject and reference showed that both devices fabricate the denture base in the same manner, via automated application of a light-cure resin in an additive CAD/CAM printer.

Performance Data

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

Biocompatibility Testing

The biocompatibility evaluation for Dentca Denture Base was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1, as recognized by FDA. The battery of testing included the following tests:

Genotoxicity .
Cytotoxicity ●
Sensitization ●
. Irritation
Acute Toxicity
. Material Characterization

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

Electrical Safety and EMC

The low voltage 3D printer used to fabricate the denture base from the Denture Base light-cure resin was certified by the printer manufacturer to conform to EN 60950 (Safety of Information Technology Equipment) and the following EMC standards: EN 55022. EN 55024, EN 61000-3-2, EN 61000-3-3, and EN 60825-1.

Software Verification and Validation Testing

The optical scanning impression system used to convert cast impressions into 3D digital images was validated by the scanner manufacturer in conformance with ISO 12836.

Bench Testing

Dentca Denture Base was tested for conformity with the industry consensus standard ISO 20795-1.

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Conclusions

The subject and predicate devices have the same intended use and substantially similar technological characteristics, with the exception of the method of fabricating the denture base. Because the subject introduces a new additive printing technology as part of a CAD/CAM manufacturing process, an acceptable reference device was brought in to demonstrate prior use of this new technology.

The non-clinical data support the substantial equivalence of the subject device and demonstrate that Dentca Denture Base should perform as intended in the specified use conditions.

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.