IPS E.MAX PRESS MULTI

K120134 · Ivoclar Vivadent, AG · EIH · Jun 25, 2012 · Dental

Device Facts

• Record ID: K120134
• Device Name: IPS E.MAX PRESS MULTI
• Applicant: Ivoclar Vivadent, AG
• Product Code: EIH · Dental
• Decision Date: Jun 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS e.max Press and IPS e.max Press Multi is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

Device Story

IPS e.max Press and IPS e.max Press Multi are all-ceramic dental materials used by dental professionals to fabricate fixed prosthetic restorations. The system consists of ceramic ingots processed via heat-pressing techniques to create custom-fit dental restorations such as veneers, inlays, onlays, crowns, and bridges. These restorations are used to replace missing tooth structure or restore dental function and aesthetics. The device is used in a dental laboratory setting by trained technicians to produce the final prosthetic, which is then placed by a dentist. The final ceramic restoration provides structural support and aesthetic replacement for damaged or missing teeth.

Clinical Evidence

Bench testing only.

Technological Characteristics

All-ceramic dental material system. Form factor: ceramic ingots for heat-pressing. Intended for fabrication of dental prosthetics (veneers, crowns, bridges).

Indications for Use

Indicated for patients requiring dental restorations including occlusal veneers, thin veneers, veneers, inlays, onlays, crowns (anterior/posterior), and 3-unit bridges (anterior/premolar) or implant-supported 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 5 2012

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

Re: K120134

Trade/Device Name: IPS e.max Press and IPS e.max Press Multi Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: June 14, 2012 Received: June 15, 2012

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. 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 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/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 vours.

Th for

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

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## Indications for Use

## 120134 510(k) Number (if known):

## lndications-For Use:-IPS-e:max-Press and-IPS-e:max Press-Multi

IPS e.max Press and IPS e.max Press Multi is an all-ceramic system for the creation of

Occlusal veneers

Thin Veneers

Veneers

Inlays

Onlays

Crowns in the anterior and posterior region

3-unit bridges in the anterior region t

3-unit bridges in the premolar region up to the second premolar as the terminal abutment

Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Lucas

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

510(k) Number: K20034