IPS 99 ONE AND IPS 99 CERAM

K121359 · Ivoclar Vivadent, AG · EIH · Jul 27, 2012 · Dental

Device Facts

• Record ID: K121359
• Device Name: IPS 99 ONE AND IPS 99 CERAM
• Applicant: Ivoclar Vivadent, AG
• Product Code: EIH · Dental
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

IPS 99 One is a one-layer veneering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ªK (26.50°C) IPS 99 Ceram is a conventional multi-layer veneering ceramic for the fabrication of metalceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ª/K (25-600°C). IPS 99 is intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.

Device Story

IPS 99 One and IPS 99 Ceram are dental veneering ceramics used by dental professionals to fabricate metal-ceramic restorations. IPS 99 One is a single-layer material; IPS 99 Ceram is a multi-layer material. Both are applied to dental alloys with specific coefficients of thermal expansion (CTE) to create inlays, onlays, veneers, and PFM crowns. These materials provide the aesthetic and functional outer layer for metal-supported dental prosthetics, benefiting patients by restoring tooth structure and appearance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Porcelain powder for clinical use (21 CFR 872.6660). Ceramic material designed for metal-ceramic restorations. Compatible with dental alloys in the CTE range of 13.8-15.0 x 10^-6/K. IPS 99 One is a single-layer formulation; IPS 99 Ceram is a multi-layer formulation.

Indications for Use

Indicated for fabrication of metal-ceramic restorations, including inlays, onlays, veneers, and anterior/posterior PFM crowns, using dental alloys with a CTE range of 13.8-15.0 x 10^-6/K.

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)

{0}------------------------------------------------

SEP 2 7 2012

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ivoclar Vivadent AG Ms. Donna Marie Hartnett, Esq. Director Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K121359

Trade/Device Name: IPS 99 One and IPS 99 Ceram Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 17, 2012 Received: July 19, 2012

Dear Ms. Hartnett:

This letter corrects our substantially equivalent letter of July 27, 2012.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

Page 2- Ms. Hartnett

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Susan Runner

☑Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{2}------------------------------------------------

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Indications for Use

K12 1359

510(k) Number (if known):

Device Name: IPS 99 One and IPS 99 Ceram

Indications For Use:

IPS 99 One is a one-layer veneering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ªK (26.50°C)

IPS 99 Ceram is a conventional multi-layer veneering ceramic for the fabrication of metalceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ª/K (25-600°C).

IPS 99 is intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.

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

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

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

| Concurrence of CDRH Office of Device Evaluation (ODE) | Page 1 of __1__ |
|-------------------------------------------------------|-----------------|
|-------------------------------------------------------|-----------------|

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

| 510(k) Number: | K121359 |
|----------------|---------|
|----------------|---------|