KAVO EVEREST ZH-BLANK

K033221 · Kavo America Corporation · EIH · Oct 28, 2003 · Dental

Device Facts

• Record ID: K033221
• Device Name: KAVO EVEREST ZH-BLANK
• Applicant: Kavo America Corporation
• Product Code: EIH · Dental
• Decision Date: Oct 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics. CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.

Device Story

KaVo Everest® ZH-Blank is a pre-formed material used by dental laboratories to fabricate dental prosthetics. The device serves as a raw material input for dental manufacturing processes. It is intended for use by dental professionals or on their order. The device provides a substrate for prosthetic construction, facilitating the creation of custom dental restorations for patients. It is a Class II medical device.

Clinical Evidence

No clinical data; bench testing only.

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 Z-Blank (K032081)
• KaVo Everest G-Blank (K030607)
• Vita inCeram Zirconia (K022996)

Submission Summary (Full Text)

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K03322

OCT 2 8 2003

### EXHIBIT 2 510(k) SUMMARY: KaVo Everest® ZH-Blank

This 510(k) summary of safety and effectiveness for KaVo Everest® ZH-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.

KaVo America Corporation Applicant:

Address: 340 East Main Street . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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® ZH-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: | K032081 KaVo Everest Z-Blank KaVo Everest G-Blank K030607 and Vita<br>inCeram Zirconia, K022996, among others. |
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| Device description: | The KaVo Everest® ZH-Blank is a pre-formed material for use by dental<br>laboratories in filling orders/prescriptions for dental prosthetics |
| Indications: | The KaVo Everest® ZH-Blank is used in the manufacture of dental<br>prosthetics.<br><br>KaVo proposes that the materials distributed within the United States be<br>labeled:<br><br>"CAUTION: Federal (US) law restricts the sale of this device to, or on the<br>order of, licensed professionals." |

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

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

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: 上一篇: 上一篇:

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 8 2003

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

Re: K033221

Trade/Device Name: KaVo Everest® ZH-Blank Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 29, 2003 Received: September 14, 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 - Mr. Kamm

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]. 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 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.

Chiu Lin, Ph.D.

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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### j) Indications for Use

510(k) Number

Device Name: KaVo Everest® ZH-Blank .

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

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"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 OR Over the Counter Use (Per 21 CFR 801.109)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: