IVOBASE HYBRID, IVOBASE HIGH IMPACT

K103391 · Ivoclar Vivadent, Inc. · EBI · Feb 17, 2011 · Dental

Device Facts

• Record ID: K103391
• Device Name: IVOBASE HYBRID, IVOBASE HIGH IMPACT
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBI · Dental
• Decision Date: Feb 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

Device Story

IvoBase Hybrid and IvoBase High Impact are PMMA-based acrylic resins used for fabricating dental prostheses, such as full and partial dentures. These materials are intended for professional use by dental clinicians or technicians in a laboratory or clinical setting. The device functions as a restorative material, processed to form the base of dental appliances. It provides the structural foundation for artificial teeth, aiding in the restoration of oral function and aesthetics for patients requiring prosthetic replacement. The device is a material-based solution rather than an automated system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PMMA-based acrylic resin for dental prostheses. Class II device under 21 CFR 872.3760. Material properties consistent with standard denture base resins.

Indications for Use

Indicated for fabrication of PMMA-based acrylic dental prostheses, including partial and full dentures, for patients requiring dental prosthetic restoration.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

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

Ms. Donna Hartnett Director of Quality Assurance/Regulatory Affairs and Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

## FEB 1 7 2011

Re: K103391

Trade/Device Name: IvoBase Hybrid and IvoBase High Impact Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 18, 2010 Received: November 19, 2010

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 yours.

Antony D. hum

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

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## Indications for Use

4103391 510(k) Number (if known):

Device Name: IvoBase Hybrid and IvoBase High Impact Indications For Use:

IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

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

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

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

Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) Page 1 of *1*
Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number: