IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE

K121230 · Ivoclar Vivadent, AG · EBF · Aug 29, 2012 · Dental

Device Facts

• Record ID: K121230
• Device Name: IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
• Applicant: Ivoclar Vivadent, AG
• Product Code: EBF · Dental
• Decision Date: Aug 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

IPS Empress Direct Color: Individualized characterization of direct and lab-fabricated composite resin restorations; masking of discolored tooth structure; characterization of chairside CAD/CAM veneers. IPS Empress Direct Opaque: Masking exposed metal surfaces when repairing defective ceramic and composite veneers intraorally; Masking of discolored tooth structure.

Device Story

IPS Empress Direct Color and Opaque are light-cured, resin-based dental materials. IPS Empress Direct Color is used for aesthetic characterization of composite restorations and veneers; IPS Empress Direct Opaque is used for masking discolored tooth structure or exposed metal during intraoral repairs. Applied by dental professionals in a clinical setting. Materials function as restorative/aesthetic adjuncts to standard composite resin procedures. No automated processing or software involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, resin-based dental materials. Formulated for direct application to composite or ceramic surfaces. No electronic components, software, or connectivity.

Indications for Use

Indicated for dental patients requiring characterization of composite resin restorations, masking of discolored tooth structure, characterization of chairside CAD/CAM veneers, or masking of exposed metal surfaces during intraoral repair of defective ceramic/composite veneers.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

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

AUG 29 2012

Ms. Donna Marie Harnett Regulatory Affairs Ivoclar Vivadent AG 175 Pineview Drive Amherst, New York 14228

Re: K121230

Trade/Device Name: IPS Empress® Direct Color and IPS Empress® Direct Opaque Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 14, 2012 Received: August 15, 2012

Dear Ms. Harnett:

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.

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## Page Ms. Harnett

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 reportung (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.html 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/Safety/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Rumm

Anthony B. Watson, BS, MS, MBA 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

K121230

510(k) Number (if known):

Device Name: IPS Empress® Direct Color and IPS Empress® Direct Opaque

Indications For Use:

IPS Empress Direct Color: Individualized characterization of direct and lab-fabricated composite resin restorations; masking of discolored tooth structure; characterization of chairside CAD/CAM veneers.

IPS Empress Direct Opaque: Masking exposed metal surfaces when repairing defective ceramic and composite veneers intraorally; Masking of discolored tooth structure.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page

Swen Rurse

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

510K application IPS Empress Direct Color & IPS Empress Direct Opaque Page 5

**510(k) Number:**