WILLI GELLER CREATION CP PORCELAIN

K043221 · Jensen Industries, Inc. · EIH · Dec 20, 2004 · Dental

Device Facts

• Record ID: K043221
• Device Name: WILLI GELLER CREATION CP PORCELAIN
• Applicant: Jensen Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Dec 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing dental porcelains.

Device Story

Willi Geller Creation CP Porcelain consists of pressable ceramic pellets; used by dental technicians in a laboratory setting to fabricate dental restorations including crowns, onlays, inlays, and veneers. The material serves as a substructure or full contour restoration; can be veneered with conventional or low-fusing dental porcelains. The device is processed by technicians to create custom dental prosthetics; final restorations are placed by dentists to restore tooth function and aesthetics for patients.

Clinical Evidence

Bench testing only; no clinical data presented. Substantial equivalence is based on mechanical and chemical property comparisons to the predicate device.

Technological Characteristics

Pressable ceramic pellets; dental porcelain material. Form factor is ceramic pellets for pressing. No electronic, software, or connectivity components.

Indications for Use

Indicated for dental patients requiring full contour restorations (crowns, onlays, inlays, veneers) or substructures for full ceramic dental restorations.

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

• Match Press pressable ceramic (K024250)

Reference Devices

• Willi Geller Creation LF (K02904)

Submission Summary (Full Text)

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# K643221

### 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 3, 2004 |
| Device Name:<br>Common Name:<br>Classification:<br>Product Code: | Willi Geller Creation CP Porcelain<br>Dental Porcelain<br>Class II<br>EIH |
| Predicate Device: | Match Press pressable ceramic: 510(k) number K024250 |

#### Device Description

Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation Ch , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2004

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

Re: K043221

Trade/Device Names: Willi Geller Creation CP Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH and ELL Dated: October 16, 2004 Received: November 22, 2004

Dear Mr. Phelps:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaused in " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass batted in also energent date of the Medical Device Amendments, or to devices that proof to they 20, 1978, are cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been toetablication in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker 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 may of subject to been all 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. Gary Phelps

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I D7T s issualled on and other complies with other requirements of the Act or that FDA nas made a decemination and Joistered by other Federal agencies. You must comply with CEP Poss Box 2007 all rederal statutes and regulations animalians in the registration and listing (21 CFR Part 807); all the Act s requirements, merading, out increasing practice requirements as set forth in the quality labeling (21 CFR Part 001), good management of the electronic product radiation systems (QB) rogs (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 witi anow you to ogin marketing of substantial equivalence of your device to a legally premits touriedition: "The PDF maning of vation 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 If you desire specific at [phone]. Also, please note the regulation entitled, contact the Office of Comphance as (210) = 6 otion't (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kuanen

Chiu S. Lin, PhD 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): K043221

Device Name: Willi Geller Creation CP Porcelain Indications for Use:

Willi Geller Creation CP Porcelain is a pressable ceramic material intended for Willi Geller Creation CP Porcelant is a preodable ventures and full contour restorations.
constructing veneer, onlay, inlay, and crown substructures and fusing constructing veneer, only, and Grown of the suitable conventional or low fusings
Veneering of substructures can be performed with suitable convention & I Veneering of substructures can be performed with Galabo or Willi Geller Creation & LF (K02904).

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suse Rower

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

510(k) Number: K413221

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