Z-BLOCK, MODELS 20/19, 40/19, 55/19

K062389 · Foundation Milling Centre · EIH · Aug 21, 2006 · Dental

Device Facts

• Record ID: K062389
• Device Name: Z-BLOCK, MODELS 20/19, 40/19, 55/19
• Applicant: Foundation Milling Centre
• Product Code: EIH · Dental
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This product is indicated for use as a substructure for porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined at the user facility using CAD/CAM technology.

Device Story

Z-Blocks consist of Zirconia Oxide (ZrO2) ceramic blocks with an attached metal chuck for CAD/CAM machine mounting. Used in dental laboratories; processed by CAD/CAM milling to create tooth cores; fired in an oven for hardening; layered with porcelain to produce finished crowns or bridges. Device provides substructure for dental restorations; benefits patient through creation of durable, custom-fitted ceramic dental prosthetics.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Material: Zirconia Oxide (ZrO2) ceramic block. Form factor: Ceramic block with integrated metal chuck for CAD/CAM machine interface. Processing: CAD/CAM milling followed by thermal firing for hardening.

Indications for Use

Indicated for use as a substructure for porcelain fused to ceramic fixed dental restorations, specifically 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

• IPS E. MAX CAED/IPS E.MAX ZIRCAD (K051705)

Submission Summary (Full Text)

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## SECTION 5. 510(K) SUMMARY OR 510(K) STATEMENT

| Submission<br>Correspondent: | Emergo Group, Inc.<br>2519 McMullen Booth Road<br>Suite 510-295<br>Clearwater, Florida 33761<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Ian P. Gordon<br>Sr. Vice President | AUG 2 1 2006 |
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| Submission Sponsor: | Foundation Milling Center (FMC)<br>235 Aero Drive<br>Buffalo, NY 14225<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Jacob Oppenheimer<br>Vice President, Product Development | |
| Date summary prepared: | May 31, 2006 | |
| Device trade name: | Foundation Milling Center Z-Blocks | |
| Device common name: | Z-Blocks | |
| Device classification name: | Porcelain Powder for Clinical Use | |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | K051705, IPS E. MAX CAED/IPS E.MAX ZIRCAD, Ivoclar Vivadent, Inc. | |
| Description of the device: | This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There<br>is a metal chuck glued on the end of the block that holds the block into the<br>CAD/CAM machine. The block is milled into cores for teeth and then is<br>fired in an oven to harden the ZrO2. Then the core is layered with ceramic<br>porcelain to make a finished tooth. | |
| Intended use of the device: | This product is indicated for use as a substructure for porcelain fused to<br>ceramic fixed dental restorations; namely crowns and bridges. Foundation<br>Milling Center Z-Blocks are machined at the user facility using CAD/CAM<br>technology. | |
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>devices are identical. There is no difference in fundamental scientific<br>technology. They are made from the same materials and have the same<br>intended use. | |
| Conclusions: | By definition, a device is substantially equivalent when the device has the<br>same intended use and the same technological characteristics as the<br>predicate device.<br><br>There are no significant differences between the Foundation Milling Center<br>Z-Blocks and the predicate devices and therefore, the Foundation Milling<br>Center Z-Blocks to not raise any questions regarding safety and<br>effectiveness.<br><br>The Foundation Milling Center Z-Blocks, as designed, are as safe and<br>effective as the predicate device, and the device is determined to be<br>substantially equivalent to the referenced predicate devices currently on<br>the market. | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of a stylized eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 1 2006

Foundation Milling Centre 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: K062389

Trade/Device Name: Z-Block 20/19, Z-Block 40/19, Z-Block 55/19 Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 15, 2006 Received: August 16, 2006

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 Eederal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not I least be actived that 1 Da determination that your device complies with other requirements mount that I Driving may Federal statutes and regulations administered by other Federal agencies. or the Act of all , vath all the Act's requirements, including, but not limited to: registration r ou intest compry was 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 ce real of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms fotor wiffication. The FDA finding of substantial equivalence of your device to a premainer notification - Fedicate 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), 11 you dome of 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 maj Secure 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,

Shi-Jie Li, 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 4. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

K062389

Z-Block 20/19, Ż-Block 40/19, Z-Block 55/19

Indications for Use:

This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

.. Ja CHI) in of Anasihesiology, General Hospital, an Cuntral, Dental Devic

: Number.

Foundation Milling Center