IPS EMPRESS COSMO INGOT

K972827 · Ivoclar North America, Inc. · EIH · Sep 17, 1997 · Dental

Device Facts

• Record ID: K972827
• Device Name: IPS EMPRESS COSMO INGOT
• Applicant: Ivoclar North America, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For preprosthetic build-up in combination with zirconium oxide root canal post

Device Story

IPS Empress Cosmo Ingot is a dental material used for preprosthetic build-up. It is designed to be used in conjunction with zirconium oxide root canal posts to restore tooth structure. The device is intended for use by dental professionals in a clinical setting. It functions as a restorative material to support prosthetic procedures, aiding in the reconstruction of damaged teeth. The output is a physical dental restoration component that provides structural support for subsequent prosthetic work, ultimately benefiting the patient by restoring function and aesthetics to the affected tooth.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence determination.

Technological Characteristics

Dental ceramic/composite ingot material for preprosthetic build-up. Designed for use with zirconium oxide root canal posts. Class II device.

Indications for Use

Indicated for preprosthetic build-up in patients requiring restoration in combination with a zirconium oxide root canal post.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1997

Mr. Peter P. Mancuso Regulatory/Quality Assurance Manager Inoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

K972827 Re: IPS Empress Cosmo Ingot Trade Name: Requlatory Class: II Product Code: EIH Dated: July 25, 1997 Received: July 30, 1997

Dear Mr. Mancuso:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Mancuso

through 542 of the Act for devices under the Electronic enrough Siz or on ontrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Info receir wire as 0 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinding of babbanderice results in a classification for your marketed predicate actes your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Joursion of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cusento /for

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known):

IPS Empress Ingot Device Name:

Indications For Use:

For preprosthetic build-up in combination with zirconium oxide root ポ canal post

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K977827

:Y:ascription Use (Por 21 CFP 2011 09)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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