IPS EMPRESS 2

K982616 · Ivoclar North America, Inc. · EIH · Sep 8, 1998 · Dental

Device Facts

• Record ID: K982616
• Device Name: IPS EMPRESS 2
• Applicant: Ivoclar North America, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration

Device Story

IPS Empress 2 is a dental restorative material used for fabricating metal-free single unit and anterior multiple unit bonded crowns and bridges. The device is utilized by dental professionals in a clinical setting to restore tooth structure. It functions as a prosthetic material, providing a durable, aesthetic alternative to metal-based restorations. The healthcare provider uses the device by shaping and bonding the restoration to the patient's prepared tooth, directly impacting the patient's oral function and aesthetic appearance.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Metal-free dental ceramic material for crown and bridge restorations. Designed for bonding to tooth structure. Class II device.

Indications for Use

Indicated for metal-free single unit and anterior multiple unit bonded crown and bridge restorations.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 SEP

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

Re : K982616 Trade Name: IPS Empress® 2 Regulatory Class: II Product Code: EIH Dated: July 25, 1998 Received: July 27, 1998

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (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" (21CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Autman for

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

Enclosure

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K982616

Page 1

510(k) Number (if known): K 982616

Device Name: IPS Empress 2

Indications For Use:

Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Rann

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