KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

K032081 · Kavo America · EIH · Jul 24, 2003 · Dental

Device Facts

• Record ID: K032081
• Device Name: KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
• Applicant: Kavo America
• Product Code: EIH · Dental
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The KaVo Everest® ZS-Blank is used in the manufacture of dental prosthetics. KaVo proposes that the materials distributed within the United States be labeled: "CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."

Device Story

KaVo Everest® ZS-Blank is a pre-formed material used by dental laboratories to fabricate dental prosthetics. The device serves as a raw material input for dental restoration manufacturing. It is intended for professional use only, restricted to sale by or on the order of a licensed professional. The material is processed by dental laboratories to create final prosthetic devices for patients requiring dental restoration.

Clinical Evidence

No clinical data. Substantial equivalence is based on comparison of formulations and intended use to legally marketed predicates.

Technological Characteristics

Pre-formed dental frame material. Classified as porcelain powder for clinical use (21 CFR 872.6660).

Indications for Use

Indicated for use in the manufacture of dental prosthetics by licensed professionals.

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

• KaVo Everest G-Blank (K030607)
• Vita inCeram Zirconia (K022996)

Submission Summary (Full Text)

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K032081

## JUL 2 4 2003 EXHIBIT 2

## 510(k) SUMMARY: KaVo Everest® ZS-Blank

This 510(k) summary of safety and effectiveness for KaVo Everest® ZS-Blank material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | KaVo America Corporation |
|------------|--------------------------|
|------------|--------------------------|

- 340 East Main Street Address: Lake Zurich, IL 60045
Manufacturer: KaVo Elektrotechnisches Werk GmbH, D-88293, Leutkirch im Allgau Germany

Contact Person: Ms. Jennifer Pottala

Telephone: [phone] (Fax) 800-323-8029

Preparation Date: June, 2003 (of the Summary)

Device Name: KaVo Everest® ZS-Blank Common Name: Dental Frame Material for Dental Prosthesis

Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76

| Predicate devices: | KaVo Everest G-Blank K030607 and Vita inCeram Zirconia,<br>K022996, among others. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Device description: | The KaVo Everest® ZS-Blank is a pre-formed material for use by dental<br>laboratories in filling orders/prescriptions for dental prosthetics |
| Indications: | The KaVo Everest® ZS-Blank is used in the manufacture of dental<br>prosthetics. |
| | KaVo proposes that the materials distributed within the United States be<br>labeled: |
| | "CAUTION: Federal (US) law restricts the sale of this device to, or on the |

order of, licensed professionals."

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## 510(k) SUMMARY KaVo Everest® ZS-Blank

Page 2

- None required. The claim of substantial equivalence is based on comparisons Performance Data: of formulations and intended uses of the KaVo devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660.
- CONCLUSION: Based on the information in the notification KaVo America believes that The KaVo Everest® ZS-Blank is substantially equivalent to cited legally marketed predicates and to the IDENTIFICATION in the classifying regulation (21 CFR 872.6660).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

KaVo America Corporation C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K032081

Trade/Device Name: KaVo Everest® ZS-Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: July 01, 2003 Received: July 08, 2003

Dear Mr. Kamm:

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 such 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 - Daniel Kamm, P.E.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

f.AW. Anderson

() Susan Runner, DDS. MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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j) Indications for Use

14032081 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: KaVo Everest® ZS-Blank .

Indications for Use: The KaVo Everest® ZS-Blank is used in the manufacture of dental prosthetics.

KaVo proposes that the materials distributed within the United States be labeled:

"CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \checkmark ***_*** OR Over the Counter Use ***_***
(Per 21 CFR 801.109)

RSBetz DVS for Dr. K. Muly

Infection Control. Den

510(k) Number: