ZIRDENT CAD/CAM BLOCKS

K081253 · C5 Medical Werks, Inc. · EIH · May 15, 2008 · Dental

Device Facts

• Record ID: K081253
• Device Name: ZIRDENT CAD/CAM BLOCKS
• Applicant: C5 Medical Werks, Inc.
• Product Code: EIH · Dental
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).

Device Story

ZirDent is a pre-formed machineable dental blank composed of yttrium oxide stabilized zirconium oxide (YTZP). Available in green (unfired), partially-sintered, or fully-sintered states. Used by dental laboratories; blanks are machined using CAD/CAM milling equipment to create patient-specific anterior or posterior crowns or bridges based on practitioner specifications. For green and partially-sintered blanks, the laboratory completes the sintering process post-machining. The final restoration is used by dental practitioners to restore tooth function and aesthetics.

Clinical Evidence

Bench testing only. Compliance with ISO 6872 standards was used to demonstrate safety and effectiveness.

Technological Characteristics

Material: Yttrium oxide stabilized zirconium oxide (YTZP) ceramic. Form: Pre-formed machineable blanks (green, partially-sintered, or fully-sintered). Standards: ISO 6872. Energy source: None (mechanical machining). Connectivity: None.

Indications for Use

Indicated for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations, including single crowns or bridgeworks, for patients requiring dental restorative treatment.

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

• Katana Zirconia (K050160)
• ZirBlank PS & FS (K070045)
• Zerion (K061804)
• Xavex-G100 (K050903)

Submission Summary (Full Text)

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K081253

Image /page/0/Picture/1 description: The image shows the logo for C5 medicalwerks. The logo consists of a flower-like symbol on the left, followed by the text "C5 medicalwerks" on the right. The flower-like symbol is made up of six curved shapes arranged in a circle. The text "C5 medicalwerks" is written in a simple, sans-serif font.

## Section 2: 510(k) Summary

MAY 15 2008

510(k) Owner: C5 Medical Werks 2451 River Road Grand Junction, CO 81505 Phone No. 970/683-7900 Fax No. 970/683-7999

Contact Person: Homer Gregory Director, Quality Assurance and Regulatory Compliance Phone No. 970/683-7900

Date of Summary: April 2, 2008

Name of Device:

Trade name - ZirDent™ CAD/CAM Blocks

Common name - Dental restorative material, ceramic dental blanks

Classification name – Porcelain powder for clinical use (21 CFR 872.6660). Class II. Product Code EIH.

*Legally marketed devices to which C5 Medical Werks is claiming equivalence:

Katana Zirconia - 510(k) number K050160 ZirBlank PS & FS - 510(k) number: K070045 Zerion - 510(k) number: K061804 Xavex-G100 - 510(k) number: K050903

*510(k) data for these devices is available on FDA's CDRH website.

Continued on next page ...

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Image /page/1/Picture/0 description: The image shows the logo for C5 medicalwerks. The logo consists of a flower-like symbol on the left and the text "C5 medicalwerks" on the right. The flower-like symbol is made up of six C-shaped petals arranged in a circle.

# Section 2: 510(k) Summary (continued)

Description of device: ZirDent is a pre-formed machineable dental blank composed of zirconia ceramic (yttrium oxide stabilized zirconium oxide [YZTP]]. ZirDent is available in green (meaning "unfired") pre-formed blanks, partially-sintered (partially fired) pre-formed blanks and fully sintered (including hot isostatic press) pre-formed blanks. ZirDent is available in different shapes, shades, and dimensions according to the customers' / dental laboratories' specifications.

#### Indications for use:

ZirDent is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.

ZirDent is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner. For the green and partially-sintered pre-formed blanks, the customer/dental laboratory completes the sintering process after machining the patient-specific crown/bridge.

Summary of technological characteristics: water insoluble, pre-formed YTZP ceramic dental blank designed to be machined into a crown or bridge per the dental practitioners' specifications. These technological characteristics are identical to the predicate devices noted in this submission.

Substantial equivalence: Testing (including ISO 6872) confirms ZirDent is as safe and effective as the predicate devices noted in this submission.

Conclusion: ZirDent is substantially equivalent to the predicate devices indicated in this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 5 2008

C5 Medical Werks, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K081253

Trade/Device Name: ZirDent™ CAD/CAM Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 30, 2008 Received: May 2, 2008

Dear Mr. Lehtonen:

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. Lehtonen

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" (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,

Chris 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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## Section 1: Indications for Use Statement

510(k) Number:_KO&125 3

Device Name: _____ZirDenf™ CAD/CAM Blocks_____________________________________________________________________________________________________________________________________

Indications for Use: ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaper

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

510(k) Number: K081253