ZR DENTAL BLOCK

K093571 · Ams Co., Ltd. · EIH · Mar 12, 2010 · Dental

Device Facts

• Record ID: K093571
• Device Name: ZR DENTAL BLOCK
• Applicant: Ams Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Device Story

Zr Dental block is a ceramic material used by dental technicians to fabricate dental prostheses. The device consists of blocks composed of ZrO2, YfO2, Y2O3, Al2O3, and trace oxides. It serves as the raw material input for CAD/CAM milling systems. Technicians use CAD/CAM software and milling equipment to transform the block into the final restoration shape (inlays, onlays, veneers, crowns, or bridges). The device is used in dental laboratories to create custom restorations that benefit patients by restoring tooth structure and function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of material properties.

Technological Characteristics

Material: ZrO2, YfO2, Y2O3, Al2O3, and trace oxides (SiO2, Fe2O3, TiO2, MnO2, Na2O). Form factor: Dental block for CAD/CAM milling. Intended for use with CAD/CAM systems.

Indications for Use

Indicated for the fabrication of all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges, using CAD/CAM systems.

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

• Zmatch Block (K083201)

Submission Summary (Full Text)

{0}------------------------------------------------

K093571

## Ams Co., Ltd.

MAR 1 2 2010

1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea (429-850) Tel: *82-31-4311751 Fax: [phone]

#### 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 Co., Ltd. 1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea Tel: *82-31-4311751 Fax: [phone]

Date Summary Prepared: Feb 19, 2010

Contact Person: Tae Choung Son / president [e-mail]

#### Device Name:

- 北京

・・・

Trade Name(s): Zr Dental block Classification Name: Porcelain Powder for Clinical Use Panel: Dental Product Code: દાન

#### Predicate Device Information:

K083201 Zmatch Block manufactured by Dentam Company. Limited

#### Device Description:

Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.

#### Intended Use:

Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

#### Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in intended use and technological characteristics, including:

*components

*indications for use

**Chemical Properties**

원동이다.

* chemical properties * performance properties

#### Conclusions:

Based on the information provided in this premarket notification Ams Co., Ltd concludes that Zr Dental block is safe and effective and substantially equivalent to predicate device as described herein.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes above a wavy line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

### MAR 1 2 2010

AMS Company, Limited C/O Mr. Claude Yang Chief Executive Official Onbix Corporation #708 Le-Meilleur Town, 837-19 Gangnam-Gu Seoul Republic of Korea 135-937

Re: K093571

> Trade/Device Name: Zr Dental Block Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 28, 2010 Received: March 9, 2010

Dear Mr. Yang:

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.

{2}------------------------------------------------

Page 2- Mr. Yang

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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ 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/ResourcesforYou/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

{3}------------------------------------------------

K093571

# Indications for Use

510(k) Number (if known): j

Device Name: Zr Dental block

Indications for Use:

. 19-18'90 08

Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DOS for Dr. K.P. Muly

Division Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices

; 10(k) Number: K093571

OOb