(167 days)
Not Found
No
The summary describes a dental material and its use in CAD/CAM milling for restorations, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is a material used for dental restorations, not a therapeutic device that treats or prevents a disease.
No
The device is a material used for creating dental restorations, not for diagnosing conditions. Its primary function is to be milled into physical prosthetics.
No
The device description clearly states it is a "ceramic-based material" and an "integrated system of dental ceramic," indicating 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 dental restorations (inlays, artificial teeth, crowns, bridges) for patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description focuses on the material itself and its use in creating prosthetic devices for patients. It doesn't mention any analysis of biological samples or diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
- Generating diagnostic results
The device is a material used in the manufacturing of medical devices (dental restorations) that are implanted or placed in the patient's mouth. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Eclipse Kiss Zirconia: This device is a ceramic based material (porcelain) that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three unit bridges) and processed by dental CAD/CAM.
Product codes
EIH
Device Description
The Eclipse Kiss Zirconia Dental Material is an integrated system of dental ceramic which support dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of dental restorations to meet the specific needs of individual dental patients. Each patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.
Eclipse Kiss Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges (up to maximum three unit bridges); which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.
Eclipse Kiss Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration is to be produced.
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
Non-Clinical Study performance: Not applicable
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
AMS % Ho Dong Yang CEO Onbix Corporation #821 Samil. Plaza, 837 -26 Yeuksam-dong Gangnam-gu Seoul, 135768 REPUBLIC OF KOREA
Re: K163238 Trade/Device Name: Eclipse Kiss Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 31, 2017 Received: February 6, 2017
Dear Ho Dong Yang: This letter corrects our substantially equivalent letter of May 4, 2017.
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. Iisting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting 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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Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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Indications for Use
510(k) Number (if known) K163238
Device Name Eclipse Kiss Zirconia
Indications for Use (Describe)
This device is a ceramic-based material that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three-unit bridges) and processed by dental CAD/CAM.
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | AMS
#530 Na-Dong Machzone, 117, Hwanggeum-ro
Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea (10048) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul, 135,768, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com |
| Date Summary Prepared: | Nov 14, 2016 |
Device Information:
| Trade Name(s): | Eclipse Kiss Zirconia |
|---|---|
| Classification Name: | dental porcelain |
| Panel: | dental |
| Product Code & Regulation: | EIH / 872.6660 |
Predicate Device Information:
K150196 / DD Cubex2
Device Description:
The Eclipse Kiss Zirconia Dental Material is an integrated system of dental ceramic which support dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of dental restorations to meet the specific needs of individual dental patients. Each patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.
Eclipse Kiss Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges (up to maximum three unit bridges); which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.
Eclipse Kiss Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration is to be produced.
Intended Use:
This device is a ceramic based material (porcelain) that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three unit bridges) and processed by dental CAD/CAM
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
Performance properties
The device was conducted in compliance with the following Standard
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ISO 10993 biological evaluation of medical devices
Summary of the technological characteristics compared to the predicate device Eclipse Kiss Zirconia is substantially equivalent to the predicate device in its technological
characteristics stated in the comparison table provided below
| Eclipse Kiss Zirconia | DD Cubex2 | |
|---|---|---|
| Manufacturer | AMS | Dental Direkt Gmbh |
| 510(k) Number | not yet assigned | K150196 |
| Product code | EIH | EIH |
| Regulation | ||
| number | 872.6660 | 872.6660 |
| Indications for | ||
| use | Ceramic based material (porcelain) that | |
| is used for prefabricated and patient- | ||
| matched dental restorations such as inlays, | ||
| artificial teeth, crowns or bridges (up to | ||
| maximum three unit bridges)and processed | ||
| by dental CAD/CAM | Dental blanks made from DD cubeX² | |
| are indicated for crowns, multi-unit | ||
| bridges (up to a maximum of three | ||
| elements) and inlay bridges. | ||
| Applications include both, anterior | ||
| and posterior bridges. | ||
| Chemical | ||
| composition | ZrO2+HfO2+Y2O3 ≥ 99 wt% | |
| Y2O3 6.0 | ||
| Coefficient of thermal expansion [10⁻⁶K⁻¹]: | ||
| 10.3 | Flexural strength [MPa] > 720 | |
| Density [g/cm³] > 6.0 | ||
| Coefficient of thermal expansion [10⁻⁶K⁻¹]: 10 | ||
| Biocompatibility | Suitable | Suitable |
Comparison table is as follows
Non-Clinical Study performance
Not applicable
Conclusion
Eclipse Kiss Zirconia is substantially equivalent to the predicate device in its intended use and technological characteristics