C&B 5.0 Hybrid

K210817 · Arum Dentistry Co., Ltd. · EBG · Dec 8, 2021 · Dental

Device Facts

• Record ID: K210817
• Device Name: C&B 5.0 Hybrid
• Applicant: Arum Dentistry Co., Ltd.
• Product Code: EBG · Dental
• Decision Date: Dec 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

C&B 5.0 Hybrid is a light-curable, methacrylate-based liquid resin used to fabricate temporary dental crowns and bridges via additive manufacturing (3D printing). The device is intended for use by dental professionals. The process requires digital dental models, a DLP/LCD 3D printer (using a 405nm UV light source), and an extra-oral curing light unit. The resin is polymerized layer-by-layer (lamination) to create the final prosthetic. The output is a temporary dental restoration used for patient treatment. The device benefits patients by providing a custom-fabricated alternative to preformed temporary crowns and bridges.

Clinical Evidence

Bench testing only. Performance was validated against ISO 10477 standards, including flexural strength, water absorption, solubility, and color stability. Biocompatibility was confirmed via ISO 10993-10 (sensitization, oral mucosal irritation) and ISO 10993-11 (acute toxicity) testing, alongside cytotoxicity assessments.

Technological Characteristics

Methacrylate oligomer-based resin with 0.01-0.1 wt% inorganic filler. Polymerization via 405nm UV laser/light. Compatible with DLP/LCD 3D printers. Layer thickness: 16, 50, 100 µm. Resolution: 0.01-0.1 mm (x, y axis). Packaging: 1000ml HDPE bottle. Standards: ISO 10477 (performance), ISO 10993 (biocompatibility).

Indications for Use

Indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment for use in the oral environment for less than 30 days.

Regulatory Classification

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.

Predicate Devices

• Resin for Temporary Crown & Bridge (K180657)

Submission Summary (Full Text)

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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

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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 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 ([e-mail]) or phone [phone] 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

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## 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) |

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# 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. [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 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.

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#### 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 |

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#### 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 &<br>Bridge | - |
| 510(K) No. | K210817 | | K180657 | - |
| Regulation Name | Denture Relining, Repairing, Or<br>Rebasing Resin | | Denture Relining, Repairing, Or<br>Rebasing Resin | same |
| Product Code | EBG | | EBG | same |
| Class | Class II | | Class II | same |
| Device<br>Identification | Light-cured resin | | Light-cured resin | same |
| Indications for<br>Use | The C&B 5.0 Hybrid is indicated for<br>the fabrication of temporary dental<br>restorations in conjunction with<br>extra-oral curing light equipment.<br>Duration is less than 30 days in oral<br>environment. | | Resin for Temporary Crown &<br>Bridge is indicated for the<br>fabrication of<br>temporary dental restorations in<br>conjunction with extra-oral curing<br>light<br>equipment. Duration is less than 30<br>days in oral environment. | same |
| Materials of Use | Titanium dioxide<br>Trimethylolpripanetrimethacrylate<br>Diphenyl phosphine oxide<br>Silicon Oxide<br>Urethane Dimethacrylate<br>Yellow<br>Red<br>Pigments<br>Black | | Titanium dioxide<br>Ethyl acrylate<br>Diphenyl phosphine oxide<br>Methyl methacrylate<br>Urethane methacrylate<br>Cesium oxide (Pigments) | similar |
| Device state | Pre-mixed liquid resin provided in a<br>container | | Pre-mixed liquid resin provided in<br>a container | same |
| Polymerization<br>(Curing) Method | Visible light | | Visible light | same |
| Fabrication of<br>Denture Base | CAD/CAM additive printing process | | CAD/CAM additive printing<br>process | 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

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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.