DENTCA DENTURE BASE

K143033 · Dentca, Inc. · EBI · Jul 21, 2015 · Dental

Device Facts

• Record ID: K143033
• Device Name: DENTCA DENTURE BASE
• Applicant: Dentca, Inc.
• Product Code: EBI · Dental
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 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 Story

Dentca Denture Base is a photosensitive, methacrylate-based resin used to fabricate removable dentures via CAD/CAM additive manufacturing. The process begins with a traditional oral casting impression, which is converted into a digital file using an optical impression system. This file directs a stereolithographic laser printer to build the denture base layer-by-layer. After bonding preformed plastic teeth, the assembly is cured in a light chamber. The device is used in dental laboratories; the final product is adjusted and fitted by a dentist. The automated 3D printing process replaces manual resin application, offering an alternative to traditional heat-cured or auto-polymerizing resins. The output is a custom-fit dental prosthesis that restores function and aesthetics for the patient.

Clinical Evidence

Bench testing only. The device was tested for conformity with ISO 20795-1, achieving a flexural strength of 90.2 MPa and flexural modulus of 2,290 MPa. Biocompatibility testing was conducted per ISO 10993-1, including genotoxicity, cytotoxicity, sensitization, irritation, and acute toxicity. No clinical data provided.

Technological Characteristics

Photosensitive, methacrylate-based resin containing photoinitiator (405 nm activation), inhibitor, and pigments. Classified as Type 4 (light-activated) acrylic resin per ANSI/ADA Specification No. 12. Form factor: liquid resin in bottles. Fabrication: stereolithographic additive printing (layer-by-layer) followed by visible light post-curing. Material properties: 90.2 MPa flexural strength, 2,290 MPa flexural modulus, 14 ug/mm3 water sorption, 1.3 ug/mm3 water solubility.

Indications for Use

Indicated for fabrication and repair of full and partial removable dentures and baseplates in patients requiring removable dental prostheses.

Regulatory Classification

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.

Predicate Devices

• Trubyte Denture Base Resin System (K032892)

Reference Devices

• EnvisionTEC E-Dent 100 (K102776)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> 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: [phone] Fax: [phone]

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

## Consultant

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

Phone: [phone] 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;<br>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.

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.

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

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 heatcured 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.

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.

| | K143033<br>Subject Device | K032892<br>Predicate Device | Differences |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Names | Dentca Denture Base | Dentsply Trubyte<br>Denture Base Resin<br>System | NA |
| Classification &<br>Product Code | 872.3760; EBI | 872.3760; EBI | SAME CLASSIFICATION |
| Intended Use | Fabrication and repair of<br>removable dentures,<br>appliances and prostheses | Fabrication and repair of<br>removable dentures,<br>appliances and prostheses | SAME INTENDED USE |
| Indication For Use | Dentca Denture Base is a light-<br>cure resin indicated for<br>fabrication and repair of full and<br>partial removable dentures and<br>baseplates. The material is an<br>alternative to traditional heat-cured<br>and auto-polymerizing resins... The device requires a<br>CAD/CAM system that includes<br>the following components not<br>part of the device: oral casting<br>impression, digital denture base<br>file created in an optical<br>impression system, stereo<br>lithographic additive printer, and<br>curing light equipment. | Trubyte Denture Base Resin<br>System is [a light-cure resin]<br>indicated for fabrication and<br>repair of dentures,<br>appliances and prostheses,<br>and for relining of denture<br>surfaces. | BOTH DEVICES ARE<br>LIGHT-CURE RESINS<br>INDICATED FOR<br>FABRICATION AND<br>REPAIR OF REMOVABLE<br>DENTAL PROSTHESES. |
| Device Description | | | |
| Acrylic Resin | Light-cure resin | Light-cure resin | SAME TECHNOLOGY |
| Chemical<br>Characterization | Methacrylate-based resins<br>with photoinitiator, inhibitor<br>and pigments | Methacrylate-based resins<br>with photoinitiator, inhibitor<br>and pigments | SAME TECHNOLOGY |
| Polymerization<br>(Curing) Method | Visible light | Visible light | SAME TECHNOLOGY |
| Product State | Pre-mixed resin | Pre-mixed resin | SAME TECHNOLOGY |
| Fabrication of<br>Denture Base | Automated 3D printing of resin<br>in multiple layers, each light-cured<br>before adding next<br>layer, with post curing in light<br>chamber | Manual application of resin<br>in multiple layers, each light-cured<br>before adding next<br>layer, with post curing in<br>light chamber | Manual vs. automated<br>application 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.