CREATION CP-ZI PORCELAIN

K070114 · Jensen Industries, Inc. · EIH · Mar 1, 2007 · Dental

Device Facts

• Record ID: K070114
• Device Name: CREATION CP-ZI PORCELAIN
• Applicant: Jensen Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.

Device Story

Creation CP-ZI is a pressable ceramic material used by dental technicians in a laboratory setting. The device consists of ceramic pellets that are pressed onto zirconia frames or used as stand-alone press ceramic to fabricate dental restorations, including veneers, inlays, and crowns/bridges. The process involves thermal pressing of the ceramic material to achieve the desired dental prosthetic shape. The final output is a custom-fabricated ceramic dental restoration. The device benefits patients by providing durable, aesthetic, and functional tooth replacements.

Clinical Evidence

Bench testing only. Data presented demonstrates that mechanical properties and chemical qualities are equivalent to predicate devices.

Technological Characteristics

Pressable ceramic pellets. Material composition and mechanical properties are equivalent to predicate ceramic systems. No electronic, software, or energy-based components.

Indications for Use

Indicated for dental technicians to construct veneers, inlays, and ceramic crowns, or to press onto zirconium oxide ceramic substructures for the construction of ceramic crowns and bridges.

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 CP (K043221)
• Willi Geller Creation ZI (K043201)

Submission Summary (Full Text)

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### Section E

# 510(k) SUMMARY

Submitted by:

Jensen Industries 50 Stillman Road North Haven CT 06473 · [phone] phone [phone] fax Contact: Gary Phelps

MAR O 1 2007

January 4, 2007 Date Prepared:

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Device Name: Common Name: Classification: Product Code:

Creation CP-ZI Porcelain Dental Porcelain Class II ETH

Predicate Devices

Willi Geller Creation CP: 510(k) number K043221 Willi Geller Creation ZI: 510(k) number K043201

Device Description

Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays. Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Creation CP-ZI substantially equivalent to the predicate devices Willi Geller Creation CP and Willi Geller Creation ZI porcelains The safety and effectiveness of Creation CP-ZI, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 3 1 2007

Re: K070114

Trade/Device Name: Creation CP-ZI Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 04, 2007 Received: January 19, 2007

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. Gary 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 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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Chin S. Lin, Ph.D.

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):** K670114

Device Name: Creation CP-ZI Porcelain

Indications for Use: Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.

Prescription Use AND/OR X (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)

Super Kumar

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