(265 days)
C&B 5.0 Hybrid resin is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer , and curing lightequipment.
The C&B 5.0 Hybrid is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
The C&B 5.0 Hybrid is made from Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1 wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. The subject device is liquid photo-curable material that is polymerized by UV laser at 405nm. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use DLP/LCD 3D Printer equipment using UV light source and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16 um.
The provided text describes a 510(k) premarket notification for a dental resin, "C&B 5.0 Hybrid." This document focuses on demonstrating the substantial equivalence of this new device to an existing predicate device rather than presenting a study proving a device meets specific acceptance criteria related to AI or clinical performance. Therefore, most of the requested information regarding AI studies, sample sizes, expert ground truth, and adjudication methods is not applicable or cannot be extracted from this particular document.
However, I can extract information related to the performance data and the standards it meets.
1. A table of acceptance criteria and the reported device performance
The document references ISO standards as the "Referenced Standard" for various tests, which implicitly define the acceptance criteria for these physical and biological properties. The reported device performance is that it "Meets" these standards.
| Test Item | Referenced Standard (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Shelf-Life Validation Tests | ||
| Visual Inspection | - | Test Performed |
| Packaging | ISO 10477 | Test Performed |
| Flexural Strength | ISO 10477 | Test Performed |
| Biocompatibility Tests | ||
| Cytotoxicity | ISO 10993-10 | Meets ISO 10993 |
| Sensitization | ISO 10993-10 | Meets ISO 10993 |
| Acute Toxicity | ISO 10993-11 | Meets ISO 10993 |
| Oral Mucosal Irritation | ISO 10993-10 | Meets ISO 10993 |
| Performance Tests | ||
| Visual Inspection | - | Test Performed |
| Packaging | - | Test Performed |
| Capacity | - | Test Performed |
| Color Consistency | - | Test Performed |
| Color Stability | ISO 10477 | Meets ISO 10477 |
| Flexural Strength | ISO 10477 | Meets ISO 10477 |
| Water Absorption | ISO 10477 | Meets ISO 10477 |
| Solubility Test | ISO 10477 | Meets ISO 10477 |
Regarding the other requested information:
- 2. Sample sized used for the test set and the data provenance: Not specified in the document. The document refers to "the following tests were performed," but details about sample sizes for each test are not provided. The data provenance is implied to be from the manufacturer's testing (Arum Dentistry Co., Ltd., South Korea), but no country of origin of patient data or retrospective/prospective nature is applicable as this is a material science and biocompatibility study, not a clinical study involving patients.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for material properties and biocompatibility is established by adherence to recognized international standards (ISO), not by expert consensus in the context of clinical interpretation or image analysis.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI medical device or an MRMC study.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on established scientific and engineering principles and adherence to international standards (e.g., ISO 10477 for dental polymer materials, ISO 10993 for biological evaluation of medical devices).
- 8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2021
Arum Dentistry Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K210817
Trade/Device Name: C&B 5.0 Hybrid Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: October 11, 2021 Received: November 08, 2021
Dear Priscilla Chung:
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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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 (if known) K210817
Device Name C&B 5.0 Hybrid
Indications for Use (Describe)
C&B 5.0 Hybrid resin is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer , and curing lightequipment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."
{3}------------------------------------------------
510(k) Summary (K210817)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Oct 12, 2021
1. Applicant / Submitter:
Arum Dentistry Co., Ltd. 44, Techno 8-ro, Yuseong-gu, Daejeon, 34028 South Korea Tel. +82-42-935-3644
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | C&B 5.0 Hybrid |
|---|---|
| Common Name: | 3D temporary crown and bridge resin |
| Classification Name: | Temporary crown and bridge resin |
| Classification: | Class II, 21 CFR 872.3770 |
| Classification Product Code: | EBG |
4. Predicate Device:
Resin for Temporary Crown & Bridge (K180657) by Dentis Co., Ltd.
{4}------------------------------------------------
5. Device Description:
The C&B 5.0 Hybrid is made from Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1 wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. The subject device is liquid photo-curable material that is polymerized by UV laser at 405nm. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use DLP/LCD 3D Printer equipment using UV light source and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16 um.
6. Indications for Use:
The C&B 5.0 Hybrid is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
7. Performance Data (Non-Clinical):
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
| Test | Test Item | Referenced Standard |
|---|---|---|
| Shelf-Life Validation Tests | Visual inspection | - |
| Packaging | ISO 10477 | |
| Flexural strength | ISO 10477 | |
| Biocompatibility Tests | Cytotoxicity | |
| Sensitization | ISO 10993-10 | |
| Acute Toxicity | ISO 10993-11 | |
| Oral Mucosal Irritation | ISO 10993-10 | |
| Performance Tests | Visual Inspection | - |
| Packaging | - | |
| Capacity | - | |
| Color Consistency | - | |
| Color Stability | ISO 10477 | |
| Flexural Strength | ISO 10477 | |
| Water Absorption | ISO 10477 | |
| Solubility Test | ISO 10477 |
{5}------------------------------------------------
8. Substantial Equivalence
The following table compares technological and other characteristics of the subject and a predicate device.
| Subject Device | Predicate Device | Comparison | ||
|---|---|---|---|---|
| Applicant | Arum Dentistry Co., Ltd. | Dentis Co., Ltd | ||
| Trade Name | C&B 5.0 Hybrid | Resin for Temporary Crown &Bridge | - | |
| 510(K) No. | K210817 | K180657 | - | |
| Regulation Name | Denture Relining, Repairing, OrRebasing Resin | Denture Relining, Repairing, OrRebasing Resin | same | |
| Product Code | EBG | EBG | same | |
| Class | Class II | Class II | same | |
| DeviceIdentification | Light-cured resin | Light-cured resin | same | |
| Indications forUse | The C&B 5.0 Hybrid is indicated forthe fabrication of temporary dentalrestorations in conjunction withextra-oral curing light equipment.Duration is less than 30 days in oralenvironment. | Resin for Temporary Crown &Bridge is indicated for thefabrication oftemporary dental restorations inconjunction with extra-oral curinglightequipment. Duration is less than 30days in oral environment. | same | |
| Materials of Use | Titanium dioxideTrimethylolpripanetrimethacrylateDiphenyl phosphine oxideSilicon OxideUrethane DimethacrylateYellowRedPigmentsBlack | Titanium dioxideEthyl acrylateDiphenyl phosphine oxideMethyl methacrylateUrethane methacrylateCesium oxide (Pigments) | similar | |
| Device state | Pre-mixed liquid resin provided in acontainer | Pre-mixed liquid resin provided ina container | same | |
| Polymerization(Curing) Method | Visible light | Visible light | same | |
| Fabrication ofDenture Base | CAD/CAM additive printing process | CAD/CAM additive printingprocess | same | |
| Post Curing | Visible light-curing unit | Visible light-curing unit | same | |
| Product State | Pre-mix resin | Pre-mix resin | same | |
| Teeth Assemble | Bonding | Bonding | same | |
| Sterilization | None | None | same | |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | same | |
| Performance Test | Meets ISO 10477 | Meets ISO 10477 | same |
The subject device has the same indications for use as the predicate device. Both devices are methacrylate-based resin and uses the same technology of CAD/CAM system to make the final prosthetic appliances. The major differences would be raw material compositions. We have
{6}------------------------------------------------
performed the biocompatibility and performance tests to support that the subject device is substantially equivalent to the predicate device despite this difference. Based on the test results submitted here in, we conclude that the subject device is substantially equivalent to the predicate device.
9. Conclusion:
Based on the testing results, Arum Dentistry Co., Ltd. concludes that the C&B 5.0 Hybrid is substantially equivalent to the predicate devices.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.