UPCERA ZIRCONIA BLANKS

K093560 · Shenyang Upcera Co., Ltd. · EIH · Jan 28, 2010 · Dental

Device Facts

• Record ID: K093560
• Device Name: UPCERA ZIRCONIA BLANKS
• Applicant: Shenyang Upcera Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jan 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Story

Upcera Zirconia Blanks consist of processed zirconia powder formed into net shapes. These blanks serve as raw material for dental laboratories to fabricate prosthetic dental devices, including artificial teeth for fixed or removable dentures, jacket crowns, facings, and veneers. The device is used by dental professionals in a laboratory setting to create custom dental restorations. The blanks are milled or shaped into the final prosthetic form, providing a durable ceramic base for dental applications. The final product benefits patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Zirconia-based ceramic material; supplied as pre-formed blanks for dental milling/fabrication; non-sterile; standalone material for dental prosthetic production.

Indications for Use

Indicated for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

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

• Bisque Zirconia Blanks, Type BYZ (K081850)

Submission Summary (Full Text)

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K093560

# SECTION 5 - 510(k) SUMMARY

### Submission Correspondent

Emergo Group, Inc.

www.emergogroup.com/

### Address

1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746

### Phone

[phone]

## Fax

[phone]

### Contact

Stuart R. Goldman

# Submission Sponsor

Shenyang Upcera Co., Ltd. 18-9B Yaoyang Road Huishan Economic Development Zone Shenbei New District Shenyang, Liaoning, P.R.C. Postal Code:110164 Tel : [phone] Fax : [phone]

### www.upcera-dental.com

#### Date Prepared

August 14, 2009

JAN 2 8 2010

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# Trade Name

Upcera Zirconia Blanks

# Regulation Name

Porcelain Powder for Clinical Use

## Regulation Number

872.6660

# Classification Name

Powder, Porcelain

## Product Code(s)

EIH

## Classification Panel

Dental Devices

# Regulatory Class

Class II

## Device Description

Upcera Zirconia Blanks are derived from zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

## Intended Use

Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

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#### Predicate Device

K081850 - Bisque Zirconia Blanks, Type BYZ

### 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 is 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 510(k) submission that the differences between the Upcera Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness. Upcera Zirconia Blanks, as designed and manufactured, are as safe and effective as the predicate device and therefore is determined to be substantially equivalent to the referenced predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Shenyang Upcera Company, Limited C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

JAN 2 8 2010

Re: K093560

Trade/Device Name: Upcera Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 10, 2009 Received: November 21, 2009

Dear Mr Goldman:

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. Goldman

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 vours,

Th

f.c.

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

510(k) Number (if known): k093560

Device Name:

Upcera Zirconia Blanks

Indications for Use:

Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and vinneers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

TELEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muhy for MSR

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(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

1