IPS E.MAX CAD/IPS E.MAX ZIRCAD

K051705 · Ivoclar Vivadent, Inc. · EIH · Oct 14, 2005 · Dental

Device Facts

• Record ID: K051705
• Device Name: IPS E.MAX CAD/IPS E.MAX ZIRCAD
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, and full ceramic 3-unit anterior bridges. IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)

Device Story

IPS e.max CAD and IPS e.max ZirCAD are dental ceramic materials used for CAD/CAM fabrication of restorations. IPS e.max CAD is a lithium disilicate glass ceramic; IPS e.max ZirCAD is a zirconia-based ceramic. Materials are supplied as machinable blocks. Dental professionals use CAD/CAM systems to mill these blocks into specific dental prosthetics (crowns, inlays, onlays, bridges). Final restorations are placed in the patient's mouth to restore tooth structure and function. Benefits include high-strength, aesthetic, full-ceramic dental reconstructions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

IPS e.max CAD: Lithium disilicate glass ceramic. IPS e.max ZirCAD: Zirconia (zirconium dioxide) ceramic. Form factor: Machinable blocks for CAD/CAM systems. Intended for dental restoration fabrication.

Indications for Use

Indicated for patients requiring full ceramic dental restorations, including crowns, inlays, onlays, and anterior/molar bridges, fabricated via CAD/CAM machining.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

OCT 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K051705

Trade/Device Name: IPS E.MAX CAD/IPS E.MAX ZIRCAD Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: September 13, 2005 Received: September 15, 2005

Dear Ms. Hartnett:

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 - Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse be actived 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 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. product rainill allow you to begin marketing your device as described in your Section 510(k) I mo lotter with a both finding of substantial equivalence of your device to a legally marketed predicated with 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 11 you t 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 other general 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,

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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## Indications for Use

KOS 1705 510(k) Number (if known):_

Device Name: IPS e.max CAD/IPS e.max ZirCAD

## Indications For Use:

IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, and full ceramic 3-unit anterior bridges.

IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)

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

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

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105 70 510(k) Number: _______________________________________________________________________________________________________________________________________________________________