BB Base 3D printing resin for denture base

K191591 · Enlighten Materials Co., Ltd. · EBI · Aug 18, 2020 · Dental

Device Facts

• Record ID: K191591
• Device Name: BB Base 3D printing resin for denture base
• Applicant: Enlighten Materials Co., Ltd.
• Product Code: EBI · Dental
• Decision Date: Aug 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Enlighten BB Base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, auto-cured or light-cured denture base resins. Enlighten BB Base should be used exclusively by dental professionals. Fabrication of denture bases with Enlighten BB Base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

Device Story

BB Base is a photosensitive, methacrylate-based resin used for additive manufacturing of full removable denture bases. The workflow involves capturing patient anatomy via an optical impression system, designing the denture base using CAD software, and printing the structure using a stereolithographic additive printer (385-405 nm light). Following printing, the device undergoes final polymerization in a UV-light curing box. The device is intended for use by dental professionals in laboratory settings. The resulting denture base provides a functional alternative to traditional heat- or auto-cured acrylic resins. Clinical benefit is derived from the precision and efficiency of the CAD/CAM fabrication process for edentulous patients.

Clinical Evidence

No clinical data. Evidence consists of bench testing for mechanical properties and biocompatibility. Mechanical testing (flexural strength, flexural modulus, residual monomer, water sorption, water solubility) confirmed compliance with ISO 20795-1. Biocompatibility testing followed ISO 10993-1, -3, -5, -10, and -11 standards. Risk assessment conducted per ISO 14971.

Technological Characteristics

Photosensitive, methacrylate-based resin containing photoinitiators (385-405 nm activation) and pigments. Classified as ISO 20795-1 Type 4 light-activated acrylic resin. Form factor: 1 kg liquid bottle. Requires external CAD/CAM system (optical scanner, CAD software, stereolithographic printer, UV post-cure unit).

Indications for Use

Indicated for the fabrication of full removable denture bases for edentulous patients in dental laboratories. For use exclusively by dental professionals.

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

• Dentca Denture Base II (K162044)

Submission Summary (Full Text)

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August 18, 2020

Enlighten Materials Co., Ltd % Chiao-Min Chang Regulatory Affairs Voler Biotech Consulting Co., Ltd. No. 3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City, 10480 TAIWAN

Re: K191591

Trade/Device Name: BB Base 3D Printing Resin for Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: July 9, 2020 Received: July 20, 2020

Dear Chiao-Min Chang:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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

Device Name: BB Base 3D printing resin for denture base Indications for Use:

Enlighten BB Base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, auto-cured or light-cured denture base resins. Enlighten BB Base should be used exclusively by dental professionals. Fabrication of denture bases with Enlighten BB Base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

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

# BB Base 3D printing resin for denture base

## 1. Contact Person

Name: Jiun Ming Su Title: Chief Financial Officer E-mail: [e-mail] Office address: 8F., NO.138, SEC. 2, JINSHAN S. RD., DA-AN DIST., TAIPEI CITY 10642, TAIWAN (R.O.C.) Tel: (O) [phone]

| Date prepared: | 2020.07.07 |
|-----------------------|-------------------------------------------------|
| Product Name: | BB Base 3D printing resin for denture base |
| Classification Name: | Denture relining, repairing, or rebasing resin. |
| Common or Usual Name: | Dental Material |
| Classification Panel: | 21 CFR 872.3760 |
| Regulation Number: | 872.3760 |
| Device Class: | Class 2 |
| Product Code: | EBI |

#### で Device Name and Classification

#### 3. Predicate Device(s)

Dentca Denture Base II K162044

## 4. Device Description

BB Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process. The BB Base 3D printing resin for denture base is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is a Type 4 (light-activated) acrylic resin as classified ISO20795-1. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D

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printer is not included with the device.

### 5. Intended Use / Indications for Use

BB Base 3D printing resin for denture base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, light-cured or light-cured denture base resins. BB Base 3D printing resin for denture base should be used exclusively by dental professionals. Fabrication of denture bases with BB Base 3D printing resin for denture base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

#### Scanner and CAD software:

| | Brand | Model |
|-----------------|------------|--------|
| Scanner | Carestream | 3600 |
| Design software | Exocad | Exocad |

Printing system:385~405nm 3D printers

| Printer Brand | Model | Software |
|---------------|-------|------------|
| Miicraft | Ultra | MiiUtility |

#### Post-Curing: 385~405nm UV box

| Post-cure unit brand | Type |
|----------------------|-----------|
| Formlabs | Form Cure |

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## 6. Comparison of technology

| | Subject Device | Predicate Device |
|---------------------------|------------------------------------------------------------|------------------------------------------------------------|
| 510(k) No. | K191591 | Dentca Denture Base II<br>(K162044) |
| Item | BB Base 3D printing resin for<br>denture base | e-dent Temporary Resin and<br>Extra-Oral |
| Classification | 2 | 2 |
| Product Code | EBI | EBI |
| Intended Use | Fabrication and repair of<br>removable dentures | Fabrication and repair of<br>removable dentures |
| Target population | Edentulus patients | Edentulus patients |
| Standard and<br>Approvals | ISO20795-1 type 4<br>(light-cure denture base<br>material) | ISO20795-1 type 4<br>(light-cure denture base<br>material) |

## Device Description

| | K191591 | K162044 | Differences |
|-----------------------------------|-----------------------------------------|-----------------------------------------|-------------|
| | Subject Device | Predicate Device | |
| Acrylic Resin | Light- Cure Resin | Light- Cure Resin | Identical |
| Chemical<br>Characterization | Methacrylate-<br>based resin | Methacrylate-<br>based resin | Identical |
| Polymerization<br>(curing) Method | Visible light | Visible light | Identical |
| Product State | Pre-mix resin | Pre-mix resin | Identical |
| Fabrication of<br>denture Base | CAD/CAM<br>additive printing<br>process | CAD/CAM<br>additive printing<br>process | Identical |
| Teeth Assemble | Bonding | Bonding | Identical |

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## Physical Properties

| | K191591<br>Subject Device | K162044<br>Predicate Device | Comparison |
|-------------------|---------------------------|----------------------------------------------------------------------------|------------------------------------|
| Flexural Strength | >85.2 MPa | >65 MPa | Met the criteria of<br>ISO 20975-1 |
| Flexural modulus | >2049 MPa | >2000 MPa | Met the criteria of<br>ISO 20975-1 |
| Viscosity | ~1180 cps | 1000 <x<2000< td=""><td>Met the criteria of<br/>ISO 20975-1</td></x<2000<> | Met the criteria of<br>ISO 20975-1 |

The physical properties of BB base are complied with ISO 20975-1, and these differences do not raise concerns of safety and effectiveness for this submission.

## 7. Performance Data

- Non-clinical performance testing
BB base has been tested for mechanical properties as part of the product specification. The most applicable standard for mechanical characteristics determination of denture base polymers and copolymers is the ISO 20975-1 Dentistry - Base polymers - Part 1: Denture base polymers.

BB base is considered a surface device, in contact with the mucosal membrane, for > 30 days. The ISO 10993-1 standard was followed, and the following biological safety aspects have been addressed:

- Cytotoxicity ISO10993-5 >
- Sensitization ISO10993-10 A
- A Irritation or intracutaneous reactivity - ISO10993-10
- Acute systemic toxicity ISO10993-11 A
- Genotoxicity ISO 10993-3 A

We also conducted a risk assessment following ISO 14971 to conform the biocompatibility.

BB base has been tested for conformity with the industry standard ISO 20795-1. BB base is compliant to the requirements defined in ISO 20975-1 for Type 4 materials.

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The following bench tests are conducted on BB base using all the compatible CAD/CAM systems, including the post-curing process:

- Flexural strength A
- > Flexural modulus
- > Residual monomer
- Water sorption A
- > Water solubility

Clinical Performance Testing ●

We did not conduct clinical performance testing for this submission device.

## 8. Conclusions:

Based on similar technology and Indications for Use as well as results of performance testing, we believe that BB Base 3D printing resin for denture base is substantially equivalent to the predicate, Dentca Denture Base II.