WILLI GELLER CREATION PORCELAIN

K981490 · Jensen Industries, Inc. · EIH · Oct 22, 1998 · Dental

Device Facts

• Record ID: K981490
• Device Name: WILLI GELLER CREATION PORCELAIN
• Applicant: Jensen Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The product is intended for use in fabricating oral crowns and bridges and laminate veneers and inlays for dental use.

Device Story

Willi Geller Creation porcelain is a dental ceramic system used by dental technicians to fabricate dental restorations, including porcelain-fused-to-metal crowns, bridges, laminate veneers, and inlays. The system consists of ceramic powders, paste opaques, stains, and various liquids (modeling, shoulder, glaze, opaque). The technician applies the ceramic materials to a substructure or model; the vehicle components (glycerol, zinc chloride, etc.) evaporate during the firing process, leaving only the ceramic material in the final restoration. The device is used in a dental laboratory setting by trained professionals to create custom prosthetic dental devices.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental ceramic system composed of silicon dioxide, aluminum oxide, sodium oxide, potassium oxide, barium oxide, and iron oxide. Pigmentation uses trace amounts of chemically stable mixed metal oxides (spinel, baddeleyit, zircon, periclase phases of zirconium, iron, cobalt, chromium, yttrium, cerium, nickel, and zinc oxides). Liquids contain zinc chloride, sodium acetate, propandiol, aerosil, tylose, and methylethylene glycol. Non-electronic, non-software device.

Indications for Use

Indicated for dental patients requiring fabrication of oral crowns, bridges, laminate veneers, and inlays.

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

• Willi Geller Creation ceramic (K900209)

Submission Summary (Full Text)

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K98/490

## SUMMARY OF DATA

Willi Geller Creation porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations including porcelain fused to metal crowns and bridges, laminate veneers, and inlays. The product is substantially equivalent to the Willi Geller Creation ceramic which was cleared via 510(k) #K900209.

The ceramic powders in the Creation porcelain system are composed in varying proportions of silicon dioxide, aluminum oxide, sodium oxide, potassium oxide, barium oxide, and iron oxide. Chemically stable mixed metal oxides, including spinel, baddeleyit, zircon, and periclase phases of zirconium, iron, cobalt, chromium, yttrium, cerium, nickel, and zinc oxides, are used in trace amounts for pigmentation. The paste opaques are comprised of ceramic powder fitting this description suspended in glycerol, zinc chloride, sodium acetate, propandiol, and aerosil. The stains are composed of silicon dioxide, aluminum oxide, tin oxide, tin oxide, barium oxide, iron oxide, and calcium oxide, and chemically stable mixed metal oxides for pigmentation. The modeling liquid is composed of zinc chloride and water. The shoulder liquid is composed of tylose and water. The glaze liquid is composed of methylethylene glycol and water. The opaque liquid is composed of zinc chloride, water, and sodium chloride. The vehicle used in the paste opaques and the liquids are evaporated during use, and are not incorporated into devices manufactured with the porcelain.

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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.

OCT 2 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John M. Slanski Research and Development JENSEN Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473

K981490 Re: Willi Geller Creation Porcelain Trade Name: Regulatory Class: II Product Code: EIH Dated: July 27, 1998 Received: August 6, 1998

Dear Mr. Slanski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Slanski

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cucenta // Soc

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):___Not_known

Willi Geller Ceramic Porcelain Device Name:

Indications For Use:

The product is intended for use in fabricating oral crowns and bridges and laminate veneers and inlays for dental use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Herald Shreves

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1490 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

5 પંચ

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