PRISMATIK CLINICAL ZIRCONIA

K060104 · Glidewell Laboratories · EIH · Mar 15, 2006 · Dental

Device Facts

• Record ID: K060104
• Device Name: PRISMATIK CLINICAL ZIRCONIA
• Applicant: Glidewell Laboratories
• Product Code: EIH · Dental
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in prosthetic dentistry to create porcelain (ceramic) prostheses. For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.

Device Story

Prismatik™ Clinical Zirconia is a zirconium oxide powder used in dental laboratory processes; supplied as blanks for fabrication of custom-fitted, all-ceramic dental restorations (anterior and posterior). Dental technicians process the material to create reinforced ceramic cores. Device is used in dental laboratories; operated by dental professionals. Output is a custom-fitted dental prosthesis; aids in restoring patient dentition. Benefits include structural reinforcement and precise fit for dental restorations.

Clinical Evidence

No clinical data. Effectiveness and suitability are assured through the wide, general use of similar predicate devices.

Technological Characteristics

Zirconium oxide powder; supplied as blanks for dental laboratory fabrication. Used for all-ceramic dental restorations with a hard ceramic core. Class II device (21 CFR 872.6660).

Indications for Use

Indicated for use in prosthetic dentistry by dental professionals (DDS/DMD) to create porcelain (ceramic) prostheses for patients requiring dental restoration.

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

• Cercon® base (Dentsply)
• Lava™ Frame (3M)
• IPS e.max ZirCAD (Ivoclar-Vivadent)

Submission Summary (Full Text)

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MAR 15 2006

K060104

### 510(k) Summary

Submitter: Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, CA 92660

> Contact Person Keith D. Allred 949-440-2683 949-440-2787 (fax)

Date of Application: January 11, 2005

#### Device Name:

- Trade Name Prismatik™ Clinical Zirconia (Prismatik™ CZ)
- · Common Name Porcelain powder for clinical use
- · Classification II
- Product Code EIH

Description: The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.

Intended Use: The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.

Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: Cercon® base (Dentsply), Lava™ Frame (3M), and IPS e.max ZirCAD (Ivoclar-Vivadent).

Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.

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# Schedule B

# Sample Device Label/Indications for Use Statement

- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Clinical Zirconia (Prismatik™ CZ) ア
- Indications for Use: ア

For use in prosthetic dentistry to create porcelain (ceramic) prostheses.

For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Mr. Keith D. Allred Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, California 92660

Re: K060104

Trade/Device Name: Prismatik™ Clinical Zirconia (Prismatik™ CZ) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: January 11, 2006 Received: January 20, 2006

Dear Mr. Allred:

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. Keith D. Allred

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that I Drivination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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" (21CFR Part 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,

Ours

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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# Schedule B

## Sample Device Label/Indications for Use Statement

- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Clinical Zirconia (Prismatik™ (Z) ♪
- Indications for Use: ♪

For use in prosthetic dentistry to create porcelain (ceramic) prostheses.

For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.

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