HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P

K102305 · Hass Corp. · EIH · Dec 3, 2010 · Dental

Device Facts

• Record ID: K102305
• Device Name: HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
• Applicant: Hass Corp.
• Product Code: EIH · Dental
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.

Device Story

HASS Zirtooth is a zirconia-based ceramic block used as a substructure for porcelain-fused dental restorations. It serves as the core material for crowns, bridges, inlays, and onlays. The device is intended for use by dental professionals in a clinical or laboratory setting. It provides a supporting structure for veneer ceramics. The material is processed to form the restoration core, which is then layered with porcelain to achieve the final dental prosthesis. The device benefits patients by providing a durable, biocompatible framework for fixed dental restorations.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with ISO 6872 (uniformity, chemical solubility, flexural strength, radioactivity, low-temperature deterioration) and ISO 9693 (coefficient of thermal expansion, bonding strength with veneer ceramic). All test results met the specified criteria.

Technological Characteristics

Zirconia ceramic block; corresponds to ISO 6872 Type 2 Class 1. Tested per ISO 6872 and ISO 9693. No software or electronic components.

Indications for Use

Indicated for patients requiring substructures for porcelain fused ceramic fixed dental restorations, including crowns, bridges, inlays, and onlays.

Regulatory Classification

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.

Predicate Devices

• Vita In-Ceram YZ® Cubes for Cerec® (K022996)

Submission Summary (Full Text)

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## 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

- 1. 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: [phone] |
| Fax | Fax: [phone] |

- 2. Submission Correspondent
LK Consulting Group 2341 W. Crescent Ave. #3, Anaheim, CA 92801 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

3. 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

- 5. 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

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ceramic restoration. The shelf life of the ceramic block is semi-permanent.

- 6. 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.

- 7. 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.

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.

- 8. Physical Characteristics
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 .
- 9. 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.

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### 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

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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 [phone] or [phone] 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

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# 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