AURA

K102984 · Sdi Limited · EBF · Dec 8, 2010 · Dental

Device Facts

• Record ID: K102984
• Device Name: AURA
• Applicant: Sdi Limited
• Product Code: EBF · Dental
• Decision Date: Dec 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.

Device Story

Aura is a light-cured, radiopaque, resin-based composite restorative material. Used by dental professionals in clinical settings for direct and indirect dental restorations. Material is applied to tooth structure or existing restorations to restore form and function. Device provides aesthetic tooth-colored filling material for anterior and posterior teeth. Benefits include structural repair of teeth, aesthetic improvement, and stabilization via splinting.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, radiopaque, resin-based composite restorative material. Formulated for dental application. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental patients requiring direct anterior/posterior restorations, veneers, core build-ups, indirect inlays/onlays, splinting, composite/porcelain repair, and sandwich technique restorations. For professional use only.

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## Public Health Service

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

Ms. Ruth Ezekiel Regulatory Affairs Associate SDI Limited 3-13 Brunsdon Street Bayswater, Victoria Australia 3153

DEC - 8 2010

Re: K102984

Trade/Device Name: Aura Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 1, 2010 Received: October 7, 2010

Dear Ms. Ezekiel:

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. Ezekiel

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Turner

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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K10 2984

510(k) Number (if known):

Device Name: Aura

Indications for Use:

Direct anterior/posterior restorations and veneers. Core build ups.

Indirect inlays, onlays and veneers.

Splinting.

Composite and porcelain repair. Sandwich technique with glass ionomers.

For professional use only.

Prescription Use:
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rann

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

510(k) Number: RCB064