(95 days)
Not Found
No
The description focuses on the material properties and manufacturing process of a dental ceramic, with no mention of AI or ML. The performance studies are based on material standards, not algorithmic performance.
No
The device is a material (zirconia-based ceram) used to manufacture restorations (crowns, bridges, inlays, onlays) and does not directly provide therapy or treatment.
No
The device is described as a material (zirconia-based ceram) used to manufacture dental restorations like crowns and bridges, not to diagnose medical conditions. The performance studies focus on material properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a zirconia-based ceramic material provided in physical shapes (square and circle) for manufacturing dental restorations. It is a physical material, 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 creating substructures for dental restorations (crowns, bridges, inlays, onlays). This is a structural component used in the body, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The device is a zirconia-based ceramic material used for manufacturing cores of dental crowns. This is a material used in a manufacturing process for a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on material properties (strength, solubility, biocompatibility) relevant to a dental restorative material, not diagnostic accuracy metrics.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Zirmon Series is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
Product codes
EIH
Device Description
The Zirmon Series is zirconia-based ceram provided in shapes of square and circle used to manufacture cores of all ceramic crowns, and is classified into ISO6872 Type 2 Class 1. This dental porcelain for cutting process is provided by shaping and semi-sintering zirconia powder and is used to manufacture ceramic restoration with cutting process by dental MAD/MAM, computer-assisted design system, or manufacturing units, CAD/CAM system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following properties were tested based on the referenced standards. All the test results met the preset test criteria.
· ISO 6872 - Package, Uniformity, Freedom from extraneous materials, Radioactivity, Chemical solubility, Flexural strength, and Linear Thermal Expansion Coefficient
- ISO 13356 Monoclinic Phase Rate and Flexural strength
- · ISO 10993-5 Cytotoxicity
- ISO 10993-11 Acute systemic toxicity
- ISO 10993-10 Oral Mucosa Irritation & Sensitization
- · Other bench testing Appearance, dimension and weight spec test
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.
0
510(k) Summary
JUL 2 6 2013
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
05/22/2013 Date: Date:
1. Submitter:
| Name: | KUWOTECH Co., Ltd.
50 Cheomdan venture so-ro, 37 beon-gil,
Buk-gu, Gwang-ju, Republic of Korea
Tel: +82-62-971-0182
Fax: +82-62-971-0185 |
|----------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | |
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 1515 E. Katella Ave. Unit 2115, Anaheim, CA 92805 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Zirmon Series |
|---|---|
| Common Name: | Dental Frame Material for Dental Prosthesis |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
4. Predicate Device:
Vita In-Ceram YZ® Cubes for Cerec® (K022996) by VITA Zahnfabrik GmbH & Co. KG
5. Device Description:
The Zirmon Series is zirconia-based ceram provided in shapes of square and circle used to manufacture cores of all ceramic crowns, and is classified into ISO6872 Type 2 Class 1. This dental porcelain for cutting process is provided by shaping and semi-sintering zirconia powder and is used to manufacture ceramic restoration with cutting process by
1
dental MAD/MAM, computer-assisted design system, or manufacturing units, CAD/CAM system.
6. Intended Use:
The Zirmon Series is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results met the preset test criteria.
· ISO 6872 - Package, Uniformity, Freedom from extraneous materials, Radioactivity, Chemical solubility, Flexural strength, and Linear Thermal Expansion Coefficient
- ISO 13356 Monoclinic Phase Rate and Flexural strength
- · ISO 10993-5 Cytotoxicity
- ISO 10993-11 Acute systemic toxicity
- ISO 10993-10 Oral Mucosa Irritation & Sensitization
- · Other bench testing Appearance, dimension and weight spec test
8. Substantial Equivalence
The Zirmon Series is substantially equivalent to the Vita In-Ceram YZ® Cubes for Cerec® (K022996). They share the same material and similar physical / chemical properties. The main difference is the dimensions and the subject device offers more shapes; however, the differences do not raise new safety or performance issues. The performance testing results presented in the 510K supports that the Zirmon Series is substantially equivalent in safety and effectiveness to the predicate device.
9. Conclusion:
Based on the testing results. KUWOTECH Co. Ltd concludes that the Zirmon Series is substantially equivalent in safety and effectiveness to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26. 2013
KUWOTECH Co., Ltd. C/O Ms. Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 1515 East Katella Avenue, Unit 2115 Anaheim. CA 92805
Re: K131117
Trade/Device Name: Zirmon Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: Ell-l Dated: May 23, 2013 Received: May 28. 2013
Dear Ms. 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. 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.
3
Page 2 - Ms. Chung:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _(13 || 17
Device Name: Zirmon Series
Indications for Use:
The Zirmon Series is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
Prescription Use V (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2013.07.30 11:51:56 -04'00'
for M. Susan Runner, DDS, MA
| (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
|---|---|
| 510(k) Number: | K131117 |