(17 days)
The KaVo Everest® ZS-Blank is used in the manufacture of dental prosthetics.
The KaVo Everest® ZS-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
This 510(k) submission for the KaVo Everest® ZS-Blank does not include a study or acceptance criteria related to a performance study of the device.
Instead, the submission states:
Performance Data: "None required. The claim of substantial equivalence is based on comparisons 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."
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data from a study for this specific device. The device's approval was based on demonstrating substantial equivalence to predicate devices, focusing on formulation and intended use, rather than a clinical performance study with specific metrics.
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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: 847-550-6800 847-550-6825 (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,K022996, among others. |
|---|---|
| Device description: | The KaVo Everest® ZS-Blank is a pre-formed material for use by dentallaboratories in filling orders/prescriptions for dental prosthetics |
| Indications: | The KaVo Everest® ZS-Blank is used in the manufacture of dentalprosthetics. |
| KaVo proposes that the materials distributed within the United States belabeled: | |
| "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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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.