(431 days)
Not Found
No
The device is a 3D printing resin and the description focuses on its material properties and the manufacturing process, not on any AI/ML capabilities within the resin itself or the associated CAD/CAM system as described.
No
The device is a material (resin) for fabricating denture bases, which are physical prosthetics. It does not directly provide therapeutic benefits on its own but is a component of a prosthetic device.
No
Explanation: The device is a resin used for fabricating denture bases. It is not designed to provide any diagnostic information about a patient's health condition.
No
The device is a 3D printing resin, which is a physical material used in the fabrication of dentures. It is not software.
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 of full removable denture bases. This is a medical device used to create a physical prosthetic for a patient.
- Device Description: The description details a photosensitive resin used in a 3D printing process to create a physical object (a denture base).
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat a disease or condition by examining specimens from the human body. IVDs are typically used to analyze blood, urine, tissue, etc.
- Performance Studies: The performance studies focus on the mechanical properties and biocompatibility of the resin, which are relevant to a medical device intended for implantation or contact with the body. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC in the context of analyzing biological samples.
- Predicate Device: The predicate device (K162044 Dentca Denture Base II) is also a denture base material, which falls under the category of medical devices, not IVDs.
In summary, the BB Base 3D printing resin is a material used to manufacture a medical device (a denture base), not a device used for in vitro diagnostic testing.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
EBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals, dental laboratories
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)
Non-clinical performance testing:
- Mechanical properties tested according to ISO 20975-1 Dentistry - Base polymers - Part 1: Denture base polymers.
- Biocompatibility testing according to ISO 10993-1, addressing:
- Cytotoxicity ISO10993-5
- Sensitization ISO10993-10
- Irritation or intracutaneous reactivity - ISO10993-10
- Acute systemic toxicity ISO10993-11
- Genotoxicity ISO 10993-3
- Risk assessment following ISO 14971 to conform biocompatibility.
- Bench tests conducted on BB base using all compatible CAD/CAM systems, including post-curing process:
- Flexural strength
- Flexural modulus
- Residual monomer
- Water sorption
- Water solubility
Key Results:
- Physical properties of BB base comply with ISO 20975-1.
- BB base is compliant to the requirements defined in ISO 20975-1 for Type 4 materials.
Clinical Performance Testing:
- No clinical performance testing was conducted for this submission device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: >85.2 MPa (Met the criteria of ISO 20975-1)
Flexural modulus: >2049 MPa (Met the criteria of ISO 20975-1)
Viscosity: ~1180 cps (Met the criteria of ISO 20975-1)
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.
Dentca Denture Base II K162044
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.
Not Found
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
§ 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.
0
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
1
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
2
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)
3
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
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
4
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 |
| (K162044) | ||
| Item | BB Base 3D printing resin for | |
| denture base | e-dent Temporary Resin and | |
| Extra-Oral | ||
| Classification | 2 | 2 |
| Product Code | EBI | EBI |
| Intended Use | Fabrication and repair of | |
| removable dentures | Fabrication and repair of | |
| removable dentures | ||
| Target population | Edentulus patients | Edentulus patients |
| Standard and | ||
| Approvals | ISO20795-1 type 4 | |
| (light-cure denture base | ||
| material) | ISO20795-1 type 4 | |
| (light-cure denture base | ||
| material) |
Device Description
| K191591 | K162044 | Differences | |
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Acrylic Resin | Light- Cure Resin | Light- Cure Resin | Identical |
| Chemical | |||
| Characterization | 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 of | |||
| denture Base | CAD/CAM | ||
| additive printing | |||
| process | CAD/CAM | ||
| additive printing | |||
| process | Identical | ||
| Teeth Assemble | Bonding | Bonding | Identical |
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Physical Properties
| | K191591
Subject Device | K162044
Predicate Device | Comparison |
|-------------------|---------------------------|----------------------------------------------------------------------------|------------------------------------|
| Flexural Strength | >85.2 MPa | >65 MPa | Met the criteria of
ISO 20975-1 |
| Flexural modulus | >2049 MPa | >2000 MPa | Met the criteria of
ISO 20975-1 |
| Viscosity | ~1180 cps | 1000 Met the criteria of
ISO 20975-1 | Met the criteria of
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.
7
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.