(109 days)
Not Found
No
The summary describes a ceramic material for dental restorations and its physical properties, with no mention of AI or ML.
No.
The device is a zirconia porcelain product used as a substructure for dental restorations, providing structural support rather than directly treating a medical condition or disease.
No
The device is a zirconia porcelain product used to make the core of all-porcelain crowns. Its intended use is as a substructure for fixed dental restorations, which is a manufacturing component rather than a diagnostic tool.
No
The device description explicitly states it is a "zirconia porcelain product" consisting of "ceramic blocks," which are physical materials, 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 the substructure of dental restorations (crowns, bridges, etc.). This is a structural component used in the mouth to support a dental prosthesis.
- Device Description: It's a ceramic block used to make the core of an all-porcelain crown. This is a material used in the fabrication of a medical device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a patient's health status.
IVD devices are typically used to perform tests on samples (like blood, urine, tissue) outside of the body to provide diagnostic information. This device is a material used in the creation of a dental prosthesis, which is a therapeutic device.
N/A
Intended Use / Indications for Use
HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
HASS Zirtooth is a zirconia porcelain product to be used to make the core of the all porcelain crown. It consists of ceramic blocks and corresponds to ISO 6872 Type 2 Class 1. This ceramic product provides the supporting structure for mounting the ceramic restoration. The shelf life of the ceramic block is semi-permanent.
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 for the device according to ISO 6872 and 9693 and all the results met the test criteria.
- ISO 6872 Uniformity, Extraneous Materials, Chemical Solubility, Flexural Strength, Radioactivity of dental ceramic and Flexural strength after the low temperature deterioration
- · ISO 9693 Coefficient of thermal expansion and Bonding strength with veneer ceramic .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for HASS Corporation. The logo is in black and features a bold, sans-serif font. The letters are closely spaced and have a modern, industrial look. The word "CORPORATION" is written in a smaller font size below the main logo.
510(k) Summary (K102305) ,
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 10/28/2010
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- Submission Sponsor
| Submitter | |
|---|---|
| Name | HASS CORP. |
| Address | Rm.301 & 306, Venture Plaza II, |
| Block Ga-2-3, Gangneung Science Park, Daejeon-dong, | |
| Gangneung, Gangwon-do, Korea | |
| Phone | Tel: +82-70-7712-1300 |
| Fax | Fax: +82-33-644-1231 |
-
- Submission Correspondent
LK Consulting Group 2341 W. Crescent Ave. #3, Anaheim, CA 92801 Priscilla Chung Phone: 714-844-2612 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
- Submission Correspondent
- Device
Trade Name: HASS Zirtooth Common Name: Dental Frame Material for Dental Prosthesis Classification Name: Porcelain Powder for Clinical Us Classification regulation: 21 CFR 872.6660
4. Predicate Device:
Vita In-Ceram YZ® Cubes for Cerec® (K022996), VITA Zahnfabrik GmbH & Co. KG
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- Description:
HASS Zirtooth is a zirconia porcelain product to be used to make the core of the all porcelain crown. It consists of ceramic blocks and corresponds to ISO 6872 Type 2 Class 1. This ceramic product provides the supporting structure for mounting the
- Description:
1
Image /page/1/Picture/0 description: The image shows the logo for HASS Corporation. The logo is in black and white. The word "HASS" is in large, bold letters. Below the word "HASS" is the word "CORPORATION" in smaller letters.
ceramic restoration. The shelf life of the ceramic block is semi-permanent.
-
- Indication for use:
HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations: namely crown, bridges, inlays, and onlays.
- Indication for use:
-
- Safety and Effectiveness:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device as safe and effective as the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
- Safety and Effectiveness:
It has been shown in this 5109(K) submission that the differences between the HASS Zirtooth and the predicate device do not raise any questions regarding its safety and effectiveness.
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- Physical Characteristics
The following properties were tested for the device according to ISO 6872 and 9693 and all the results met the test criteria.
- Physical Characteristics
-
ISO 6872 Uniformity, Extraneous Materials, Chemical Solubility, Flexural Strength, Radioactivity of dental ceramic and Flexural strength after the low temperature deterioration
-
· ISO 9693 Coefficient of thermal expansion and Bonding strength with veneer ceramic .
-
- Conclusion
Based on the information provided in this premarket notification, HASS Zirtooth is safe, effective and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hass Corporation C/O Ms. Priscilla Chung LK Consulting Group 2341 W. Crescent Avenue #3 Anaheim, California 92801
Re: K102305
Trade/Device Name: Hass Zirtooth Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: October 13, 2010 Received: November 12, 2010
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.
DEC - 3 2010
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 device-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), i please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Wh. for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
DEC - 3 2010
510(k) Number (if known): K102305
Device Name: Hass Zirtooth
Indications for Use:
HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
Prescription Use (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 NEE DED)
Concurrence of CDRH, Office of Device Evaluation
וויוצועיו בוקר Division of Anesthesicilogy, General Hue, .... Infection Control, Dental Devices
Number: K102305