(87 days)
Not Found
No
The summary describes dental materials (zirconia blocks and coloring liquid) and their use in traditional CAD/CAM milling processes, with no mention of AI or ML.
No
This device is for the construction of custom-made all-ceramic restorations and their shading by dental technicians. It is a material used in the fabrication process, not a device that directly treats a patient or provides a therapeutic effect.
No
The device is a material used for the construction of all-ceramic dental restorations and a liquid for shading these restorations. Its function is to create physical dental components, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly indicates that the device is a physical, zirconia-based ceramic material (Razor and Everest) and a water-based solution (U&C Liquid), not software. The performance studies also focus on the physical and chemical properties of these materials.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the construction of custom-made dental restorations (crowns) for anterior and posterior locations. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device consists of zirconia-based ceramic blocks and a coloring liquid. These are materials used in the fabrication of the dental restoration.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The coloring liquid is used to match the color of the restoration to the patient's existing teeth, which is an aesthetic and functional consideration, not a diagnostic one.
- Intended User: The intended user is a dental technician, who is involved in the fabrication of the device, not in performing diagnostic tests.
IVDs are specifically designed to perform tests on biological samples to provide information about a person's health status. This device is a material and an accessory used in the creation of a dental prosthesis.
N/A
Intended Use / Indications for Use
The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
U&C Liquid can be used as an accessory to zirconium dioxide dental to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Razor and Everest are zirconia-based ceramic provided in various shapes such as round and square, and they are used to manufacture cores of all ceramic crowns, and are classified into ISO 6872 Type 2 Class 5.
They are used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 31 different shades A0, A1, A2, A3, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, ML A1, ML A2, ML A3, ML A4, ML B1, ML B2, ML B3, ML B4, ML C1, ML C2, ML C3. ML C4. ML D2. ML D3. ML D4 to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
U&C Liquid is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 25 shades. 25 shades are available in 30ml, 50ml and 100ml volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior location (for teeth/dental restorations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental technicians
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 Testing:
- Biocompatibility testing: Cytotoxicity test in accordance with ISO 10993-5, Irritation and Skin Sensitization test in accordance with ISO 10993-10, Subacute/Subchronic Toxicity in accordance with ISO 10993-11.
- Performance tests for the blocks in accordance with ISO 6872 and ISO 13356 including Radiation Emission, Flexural Strength, Flexural Strength after low thermal heating, Thermal Expansion Coefficient, Monoclinic Phase Rate, Other bench testing - Appearance, Dimensions, Packaging, Uniformity, Free from extraneous materials
- Performance tests for the liquid in accordance with ISO 6872, ISO 7491, ISO 6872, ISO 10271 including Appearance, Capacity, Packaging, Color Stability, and Extraction
- Shelf life test for U&C Liquid
Key Results: The test results supported that the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- CTE (coefficient of thermal expansion) for Razor and Everest: (10.3 +/- 0.5) x 10^-6 K^-1 (meeting the ISO 6872 requirement)
- Flexural strength for Razor and Everest: >500MPa (meeting the ISO 6872 requirement)
- Chemical solubility for Razor and Everest:
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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October 11, 2019
U&C International Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K191902
Trade/Device Name: Razor, Everest, U&C Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: July 10, 2019 Received: July 16, 2019
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.
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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 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.
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Razor, Everest, U&C Liquid
Indications for Use (Describe)
The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
U&C Liquid can be used as an accessory to zirconium dioxide dental to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K191902
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 10, 2019
1. Applicant / Submitter
U&C International Co., Ltd. RM 1F/2F, 13, Digital-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-02-865-7714
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine CA 92620 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
3. Device
- י Trade Name: Razor, Everest, U&C Liquid
- י Common Name:
Dental Frame Material for Dental Prosthesis Liquid Stain for Dental Zirconium Prosthesis
- י Classification Name: Porcelain Powder for Clinical Use
- י Product Code: EIH
- Classification regulation: Class II, 21 CFR 872.6660 י
4. Predicate Device
BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) by Talladium, Inc.
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5. Description:
Razor and Everest are zirconia-based ceramic provided in various shapes such as round and square, and they are used to manufacture cores of all ceramic crowns, and are classified into ISO 6872 Type 2 Class 5.
They are used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 31 different shades A0, A1, A2, A3, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, ML A1, ML A2, ML A3, ML A4, ML B1, ML B2, ML B3, ML B4, ML C1, ML C2, ML C3. ML C4. ML D2. ML D3. ML D4 to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
U&C Liquid is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 25 shades. 25 shades are available in 30ml, 50ml and 100ml volumes.
6. Indication for use:
The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
U&C Liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
7. Basis for Substantial Equivalence
7.1. Razor™ and Everest
The subject device is substantially equivalent to the predicate device, BruxZir™ Anterior (K143330) made by Prismatik Dentalcraft. Inc. Both the device has the same indications for Use, materials, and technological characteristics. The composition rate might be different between the devices, however, the subject device meets the requirements of ISO 6872 and 10993, therefore, these difference does not raise a question in substantial equivalence.
| Subject Device | Predicate Deice | |
|---|---|---|
| 510(k) Number | - | K143330 |
| Device Name | Razor, Everest | BruxZirTM Anterior |
| Common Name | Porcelain, Powder for clinical use | Porcelain, Powder for clinical use |
| 510k Applicant | U&C International | Prismatik Dentalcraft, Inc. |
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| Indication For Use | The Razor and Everest are indicated for use
by dental technicians in the construction of
custom made all ceramic restorations for
anterior and posterior location. | The device is indicated for use by dental
technicians in the construction of custom
made all ceramic restorations for anterior and
posterior location. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CTE(coefficient of
thermal expansion) | $(10.3\pm0.5)\times10^{-6}K^{-1}$
(meeting the ISO 6872 requirement) | $11 \times10^{-6}K^{-1}$
(meeting the ISO 6872 requirement) |
| Flexural strength | >500MPa
(meeting the ISO 6872 requirement) | >650MPa
(meeting the ISO 6872 requirement) |
| Chemical solubility | $