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.

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 printer is not included with the device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device Name: BB Base 3D printing resin for denture base
Predicate Device: Dentca Denture Base II (K162044)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are largely based on the ISO 20795-1 standard for "Dentistry - Base polymers - Part 1: Denture base polymers" and comparisons to the predicate device.

Performance Metric	Acceptance Criteria (ISO 20795-1 where applicable)	Reported Device Performance (BB Base)	Comparison to Predicate (Dentca Denture Base II)
Material Properties
Flexural Strength	> 65 MPa (Predicate's value, implied as threshold)	> 85.2 MPa	Met the criteria of ISO 20975-1
Flexural Modulus	> 2000 MPa (Predicate's value, implied as threshold)	> 2049 MPa	Met the criteria of ISO 20975-1
Viscosity	1000 < x < 2000 cps (Predicate's value)	~ 1180 cps	Met the criteria of ISO 20975-1
Cytotoxicity	Biocompatible (based on ISO 10993-5)	Addressed/Compliant	Not directly compared, but both aim for biocompatibility
Sensitization	Biocompatible (based on ISO 10993-10)	Addressed/Compliant	Not directly compared
Irritation/Intracutaneous Reactivity	Biocompatible (based on ISO 10993-10)	Addressed/Compliant	Not directly compared
Acute Systemic Toxicity	Biocompatible (based on ISO 10993-11)	Addressed/Compliant	Not directly compared
Genotoxicity	Biocompatible (based on ISO 10993-3)	Addressed/Compliant	Not directly compared
Residual Monomer	Compliant with ISO 20795-1 requirements	Tested, presumed compliant	Not directly specified for predicate
Water Sorption	Compliant with ISO 20795-1 requirements	Tested, presumed compliant	Not directly specified for predicate
Water Solubility	Compliant with ISO 20795-1 requirements	Tested, presumed compliant	Not directly specified for predicate

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

The document does not specify the sample sizes used for the non-clinical performance tests (e.g., how many samples were tested for flexural strength, viscosity, etc.).

The data provenance is from non-clinical performance testing conducted by the manufacturer, Enlighten Materials Co., Ltd. The country of origin of the data is not explicitly stated, but the company's address is in Taiwan. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of an ongoing clinical trial.

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

This section is not applicable as the studies described are non-clinical (bench testing of material properties and biocompatibility). There is no "ground truth" in the clinical sense established by human experts for this type of testing. The "ground truth" here is the adherence to defined material standards (ISO).

4. Adjudication Method for the Test Set

This section is not applicable for non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where multiple human readers or experts assess outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "We did not conduct clinical performance testing for this submission device."

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

This section is not applicable. The device is a 3D printing resin, not an algorithm or an AI-powered system that would have "standalone" performance in the context of human-in-the-loop. The "performance" here refers to the physical and biological properties of the material.

7. The Type of Ground Truth Used for the Test Set

The "ground truth" for the non-clinical test set is based on:

International Standards: Primarily ISO 20795-1 for mechanical properties and ISO 10993 series for biocompatibility.
Predicate Device Performance: The predicate device's established performance values (e.g., for flexural strength, flexural modulus, viscosity) also serve as a benchmark for substantial equivalence comparisons.

8. The Sample Size for the Training Set

This section is not applicable. As a physical material (3D printing resin), there is no "training set" in the context of AI/ML algorithms. The product's properties are inherent to its formulation and manufacturing process, evaluated through bench tests.

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

This section is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: jimmy.su.js@gmail.com Office address: 8F., NO.138, SEC. 2, JINSHAN S. RD., DA-AN DIST., TAIPEI CITY 10642, TAIWAN (R.O.C.) Tel: (O) +886956973958

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

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printer is not included with the device.

5. Intended Use / Indications for Use

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(K162044)
Item	BB Base 3D printing resin fordenture base	e-dent Temporary Resin andExtra-Oral
Classification	2	2
Product Code	EBI	EBI
Intended Use	Fabrication and repair ofremovable dentures	Fabrication and repair ofremovable dentures
Target population	Edentulus patients	Edentulus patients
Standard andApprovals	ISO20795-1 type 4(light-cure denture basematerial)	ISO20795-1 type 4(light-cure denture basematerial)

Device Description

	K191591	K162044	Differences
	Subject Device	Predicate Device
Acrylic Resin	Light- Cure Resin	Light- Cure Resin	Identical
ChemicalCharacterization	Methacrylate-based resin	Methacrylate-based resin	Identical
Polymerization(curing) Method	Visible light	Visible light	Identical
Product State	Pre-mix resin	Pre-mix resin	Identical
Fabrication ofdenture Base	CAD/CAMadditive printingprocess	CAD/CAMadditive printingprocess	Identical
Teeth Assemble	Bonding	Bonding	Identical

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Physical Properties

	K191591Subject Device	K162044Predicate Device	Comparison
Flexural Strength	>85.2 MPa	>65 MPa	Met the criteria ofISO 20975-1
Flexural modulus	>2049 MPa	>2000 MPa	Met the criteria ofISO 20975-1
Viscosity	~1180 cps	1000 <x<2000< td="">Met the criteria ofISO 20975-1</x<2000<>	Met the criteria ofISO 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.

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.