WILLI GELLER CREATION ZI PORCELAIN

K043201 · Jensen Industries, Inc. · EIH · Jan 11, 2005 · Dental

Device Facts

• Record ID: K043201
• Device Name: WILLI GELLER CREATION ZI PORCELAIN
• Applicant: Jensen Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Jan 11, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations

Device Story

Willi Geller Creation ZI Porcelain is a dental ceramic material used by dental technicians in a laboratory setting. The material is applied as a veneer over zirconium oxide-based cores and substructures to create dental restorations. The device functions as a restorative material, providing the necessary mechanical and chemical properties to form durable dental prosthetics. It is intended for prescription use only.

Clinical Evidence

No clinical data; substantial equivalence is based on mechanical and chemical property testing.

Technological Characteristics

Dental porcelain powder for clinical use. Designed for veneering zirconium oxide-based cores. Class II device (Product Code EIH).

Indications for Use

Indicated for use by dental technicians to fabricate dental restorations by veneering zirconium oxide-based cores and substructures.

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 AV Porcelain (K002041)
• Lava Ceram (K011394)

Submission Summary (Full Text)

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JAN, 11, 2005

K043201

## Section E

## 510(k) SUMMARY

| Submitted by: | Jensen Industries<br>50 Stillman Road<br>North Haven CT 06473<br>[phone] phone<br>[phone] fax<br>Contact: Gary Phelps |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 1, 2004 |
| Device Name:<br>Common Name:<br>Classification:<br>Product Code: | Willi Geller Creation ZI Porcelain<br>Dental Porcelain<br>Class II<br>EIH |
| Predicate Devices: | Willi Geller Creation& AV Porcelain: 510(k) number K002041<br>Lava Ceram: 510(k) number K011394* |

## Device Description

Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation ZI substantially equivalent to the predicate device Willi Geller Creation& AV Porcelain. The safety and effectiveness of Willi Geller Creation ZI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.

* see page 10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name in a ring around the outside. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2005

Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473

Re: K043201

Trade/Device Name: Willi Geller Creation ZI Porcelain Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: October 12, 2004 Received: November 18, 2004

Dear Mr. Phelps:

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. Phelps

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 modifine in or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal backed as a requirements, including, but not limited to: registration Tournust comply with an are reveling (21 CFR Part 801); good manufacturing practice alle listing (21 CFR Part 807), and lite 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) This letter wiff anon yourse Finding of substantial equivalence of your device to a premits clothed.com - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), if you desire specific at Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entition, "Therefinance al information on your responsibilities under the Act from the may obtain 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,

Owe

Tillman, Liu, Ph.D.

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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## Indications for Use

510(k) Number (if known): K043201

Device Name: Willi Geller Creation ZI Porcelain

Indications for Use: Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K04320

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