ZIROX

K092630 · Zencera, Inc. · EIH · Oct 22, 2009 · Dental

Device Facts

• Record ID: K092630
• Device Name: ZIROX
• Applicant: Zencera, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Device Story

ZIROX is a pre-formed, partially-sintered zirconium oxide ceramic blank. Used by dental laboratories to manufacture all-ceramic dental restorations (inlays, onlays, veneers, crowns, bridges). Operates via CAD/CAM milling centers; dental technicians design and machine the blank into the final restoration shape. Provides a biocompatible, high-strength material for dental prosthetics. Benefits patients by enabling precise, durable, and aesthetic all-ceramic tooth replacements.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material properties and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Pre-formed, partially-sintered zirconium oxide ceramic blank. Available in dimensions 51x23x16mm and 51x23x18mm. Designed for CAD/CAM milling. Biocompatible material.

Indications for Use

Indicated for patients requiring all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges, fabricated via CAD/CAM processes.

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

• Dentsply-Cercon Base (K013230)
• 3M-LAVA Zirconia (K011394)
• Sagemax Bioceramics-Sagemax Z-Blank (K062695)

Submission Summary (Full Text)

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K092630

## 510(k) SUMMARY

## OCT 2 2 2009

## Submitter:

| Name: | |
|----------|----------------------|
| | Carreland Controller |
| Address: | |

ZENČERA, INC. Room 1108, ACE Techno Tower 5th Building, 197-22, Guro3-Dong, Guro-Gu, Seoul, Republic of Korea, 152-766

| Name: | Haeryang Joo |
|------------|----------------------------------------------------|
| Address: | 4525 Wilshire Blvd., Los Angeles, CA, 90010, U.S.A |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| E-Mail: | [e-mail] |

## Official Correspondent:

| Name: | San-ho Hyun |
|------------|------------------------------------------------------------------------------------------------------------|
| Address: | Room 1108, ACE Techno Tower 5th Building, 197-22, Guro<br>Dong, Guro-Gu, Seoul, Republic of Korea, 152-766 |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| E-Mail: | [e-mail] |

## Device Identification

| Proprietary Name: | ZIROX |
|----------------------|-----------------------------------|
| Common/Usual Name: | Porcelain Powder |
| Classification Name: | Porcelain Powder for Clinical Use |
| Product Code: | EIH |
| Review Panel: | Dental |
| Regulation Number: | 872.6660 |

# Substantially Equivalent Predicate Legally Marketed Devices

The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.

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| Device Name | Dentsply-Cercon<br>Base | 3M-LAVA Zirconia | Sagemax<br>Bioceramics-<br>Sagemax Z-Blank |
|-------------------|-----------------------------|-----------------------------|--------------------------------------------|
| 510(k) Number | K013230 | K011394 | K062695 |
| Decision Date | 10/25/2001 | 06/29/2001 | 10/20/2006 |
| Decision | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Product Code | EIH | EIH | EIH |
| Regulation Number | 872.6660 | 872.6660 | 872.6660 |

#### Device Description

ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height).

ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.

#### Indications for Use

The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

### Technological Characteristics and Substantial Equivalence

ZIROX and predicate devices are identical in intended use and material. Therewith, ZIROX and predicate devices are biocompatible and have similar biomechanical strength and properties.

Based on the discussion above, ZENCERA, INC. believes that ZIROX is substantially equivalent in comparison with predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized emblem, which includes an abstract representation of a human figure.

:

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Sanho Hyun Assistant Manager Zencera, Incorporated Ace Techno Tower 5th, Room 1108 197-22 Guro-3Dong, Guro-Gu Seoul 152766 REPUBLIC OF KOREA

OCT 22 2009

Re: K092630

Trade/Device Name: ZIROX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use 7Regulatory Class: II Product Code: EIH Dated: August 13, 2009 Received: August 27, 2009

Dear Mr. Hyun:

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.

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.

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Page 2 - Mr. Hyun

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting 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

K092630

510(k) Number (if known): Device Name: ZIROX Indications for Use:

> The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Kein Hurley for WSR

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

510(k) Number: K 092630