(264 days)
No
The device description and performance studies focus on the chemical properties and coloring process of a liquid solution, with no mention of AI or ML technologies.
No
The device is used to color pre-sintered zirconia for dental restorations, not to treat or cure a disease or condition in a patient. It is an accessory for fabricating dental materials.
No
Explanation: The device is a coloring solution used to shade zirconium dioxide dental restorative material, not to diagnose a medical condition or disease. The product description indicates it's used for fabrication to match natural teeth color.
No
The device description explicitly states it is a "color solution" used to color zirconia, indicating it is a liquid chemical substance, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide individual tooth shading for zirconium dioxide dental restorations. This is a process performed on a material outside the body to prepare it for implantation.
- Device Description: The device is a color solution used to color a pre-sintered zirconia body. This is a material processing step, not a test performed on a biological sample.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, disease, or condition. This device does not interact with or analyze any biological samples.
The device is clearly intended for use in the fabrication of dental restorations, which falls under the category of medical devices used in dentistry, but not specifically IVDs.
N/A
Intended Use / Indications for Use
Perfit CL 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.
Product codes
EIH
Device Description
This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth (or teeth)
Indicated Patient Age Range
General, mostly adults
Intended User / Care Setting
Certified 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 Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Shelf- Life Test
- = ISO 10993-3- Genotocixity (Ames test) & Genotocixity (Micronucleus)
- = ISO 10993-5- Cytotoxicity
- ISO 10993-10 Sensitization & Irritation
- = ISO 10993-11 Acute systemic toxicity (Oral)
- = Other bench testing- Appearance, Volume, Packaging, Dissolution analysis, Color stability
Bench test results allowed to conclude that Perfit CL is substantially equivalent to the predicate devices for its intended use.
Clinical Test Conclusion: Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
June 20, 2023
Vatech mcis Co., Ltd. % Dave Kim MTech Group 7505 Fannin St. Ste 610 Houston, Texas 77054
Re: K223029
Trade/Device Name: Perfit CL Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 22, 2023 Received: May 22, 2023
Dear Dave Kim:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA 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) K223029
Device Name
Perfit CL
Indications for Use (Describe)
Perfit CL 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
K223029
The following 510(k) summary is being submitted as required by 21 CFR 807.92;
| 5.1 Submitter: | Vatech mcis Co., Ltd.
C-Dong, 2544, Nambuk-daero, Idong-eup, Cheoin-gu,
Yongin-si, Gyeonggi-do, South Korea (17137)
Phone No. +82-31-8005-1855
Fax No. +82-31-8005-1888 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kim, Gyeong Rok
Phone: +82-31-8005-1855
E-mail: gyeongrok.kim@vatechmcis.com |
| Official Correspondent: | Dave Kim, MBA
Mtech Group
7505 Fannin St. Suite 610, Houston, TX
Tel: 713-467-2607
E mail: davekim@mtechgroupllc.com |
| Date Prepared: | June 18, 2023 |
5.2 Device Identification
| Device Trade Name | Perfit CL |
|---|---|
| Common Name | Coloring liquid for dental zirconium oxide ceramic |
| Classification Name, Number | Porcelain Powder for Clinical Use (21 CFR |
| 872.6660) | |
| Device Classification | II |
| Product Code | EIH |
5.3 Predicated or legally marketed devices which are substantially equivalent
· Primary Predicate device: K173769, "DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid", manufactured by "DMAX Co, Ltd."
5.4 Device Description
This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion.
ર્સ્ડ Statement of Indication for use
Perfit CL 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.
4
Non-clinical Test Conclusion 5.6
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Shelf- Life Test
- = ISO 10993-3- Genotocixity (Ames test) & Genotocixity (Micronucleus)
- = ISO 10993-5- Cytotoxicity
- ISO 10993-10 Sensitization & Irritation
- = ISO 10993-11 Acute systemic toxicity (Oral)
- = Other bench testing- Appearance, Volume, Packaging, Dissolution analysis, Color stability
Bench test results allowed to conclude that Perfit CL is substantially equivalent to the predicate devices for its intended use.
5.7 Clinical Test Conclusion
Clinical testing was not required for this submission.
5.8 Technical Characteristics and Substantial Equivalence
The following table shows similarities and differences of Packaging Volume, Shade and Storage Conditions between our device and the predicate devices.
| No. | Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|---|
| 1 | Device Name | Perfit CL | DMAX coloring liquid | |
| Chang's liquid | ||||
| Confident coloring liquid | ||||
| CAMeleon coloring liquid | ||||
| 2 | Manufacturer | Vatech mcis Co., Ltd | DMAX Co., Ltd. | |
| 3 | 510(k) Number | K223029 | K173769 | |
| 4 | Product Code | EIH | EIH | |
| 5 | Class | II | II | |
| 6 | Review Panel | Dental | Dental | |
| 7 | Technology | Water-based with | ||
| inorganic | ||||
| pigments | Water-based with | |||
| inorganic | ||||
| pigments | Same as predicate | |||
| 8 | Indications for | |||
| Use | Perfit CL 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 | DMAX coloring liquid, | |||
| Chang's liquid, Confident | ||||
| coloring liquid, and | ||||
| CAMeleon coloring 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. | Same as predicate | |||
| 9 | Principles of | |||
| Operation | Brush or immerse zirconia | |||
| ceramic with coloring | ||||
| liquid before sintering | Brush or immerse zirconia | |||
| ceramic with coloring | ||||
| liquid before sintering | Same as predicate | |||
| 10 | Prescription Use | Prescription only | Prescription only | Same as predicate |
| 11 | Target | |||
| population | General, mostly adults | General, mostly adults | Same as predicate | |
| 12 | Type of | |||
| Packaging | Liquid container | Liquid container | Same as predicate | |
| 13 | Packaging | |||
| Volume(ml) | 20 and 50mL | 15,20,30,40 and 100mL | No significant difference. | |
| The dose is different but it | ||||
| can be differentiated | ||||
| depending on experts' | ||||
| determination. That is, | ||||
| dose is not relevant to | ||||
| clinical performance and | ||||
| safety. | ||||
| 14 | Shade | 27 colors | 45 colors | No significant difference. |
| The shade is different but | ||||
| it can be differentiated | ||||
| depending on experts' | ||||
| determination. That is, | ||||
| dose is not relevant to | ||||
| clinical performance and | ||||
| safety. | ||||
| 15 | Storage | |||
| Conditions | 2 years at 0-25 °C | 1 year at 2-28 °C | No significant difference. | |
| The storage temperature | ||||
| is a little different but the | ||||
| storage temperature does | ||||
| not cause any clinical | ||||
| performance and safety | ||||
| issue will not be caused | ||||
| by the storage | ||||
| temperature if stored at | ||||
| the recommended | ||||
| storage temperature. | ||||
| 16 | General | |||
| Physical | ||||
| Form | Liquid | Liquid | Same as predicate | |
| 17 | Sterility | Non-Sterile | Non-Sterile | Same as predicate |
| 18 | pH | 5.5~8.0 | 5.5~8.0 | Same as predicate |
| 19 | Boiling Point | 100°C | 100°C | Same as predicate |
| 20 | Density | 1.00~1.10 g/cm^3 | 1.00~1.10 g/cm^3 | Same as predicate |
| 21 | Specific Gravity | |||
| (Relative Density) | 1.00~1.10 | 1.00~1.10 | Same as predicate | |
| 22 | Solubility in | |||
| Water | 100% | 100% | Same as predicate | |
| 24 | Biocompatibility | |||
| y Testing | Tested to ISO 10993-1 | Tested to ISO 10993-1 | Same as predicate | |
| 25 | Performance | |||
| Testing | Tested to ISO 6872 | Tested to ISO 6872 | Same as predicate |
Table 1. General Device Characteristics Comparison Table
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Submitter: Vatech mcis Co., Ltd
Perfit CL Premarket Notification: Traditional 510(k)
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The subject device is substantially equivalent to the predicate device, DMAX coloring liquid, Chang's liquid, Confident coloring liquid, CAMeleon coloring liquid, (K173769) made by DMAX Co., Ltd. Both the device has the same indications for Use and technological characteristics. They even have the same pH, boiling point, density and specific gravity range. Both devices are soluble in water. The raw material composition rate might be different between the devices, however, the subject device meets the requirements ISO 10993, therefore, this difference would not raise a question in substantial equivalence.
| 5.9 | Conclusion | Based on the testing results, Vatech mcis Co., Ltd concludes that the
subject device is substantially equivalent to the predicate device. |
|------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.10 | Declarations | This summary includes only information that is also covered in the
body of the 510(k).
This summary does not contain any puffery or unsubstantiated
labeling claims. |