TURBO TEMP 3

K102753 · Danville Materials, Inc. · EBG · Feb 4, 2011 · Dental

Device Facts

• Record ID: K102753
• Device Name: TURBO TEMP 3
• Applicant: Danville Materials, Inc.
• Product Code: EBG · Dental
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

Device Story

Turbo Temp 3 is a syringeable acrylic provisional composite material. It is used by dental professionals for the fabrication of temporary crowns and bridges. The material is applied to the prepared tooth site to provide a temporary restoration during the interval between tooth preparation and the placement of a permanent prosthetic. It functions as a restorative material to maintain space, protect the prepared tooth, and provide aesthetics and function for the patient during the healing or laboratory fabrication period.

Clinical Evidence

Bench testing only.

Technological Characteristics

Syringeable acrylic provisional composite material. Formulated for temporary crown and bridge applications. Class II device under 21 CFR 872.3770.

Indications for Use

Indicated for use as a syringeable acrylic provisional composite for temporary crown and bridge placement in dental patients.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of a human figure with three flowing lines extending upwards, representing growth and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Food and Drug Administration l 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Lindsay Tilton Regulatory Affairs Danville Materials; Incorporated 3420 Fostoria Way, Suite A-200 San Ramon, California 94583

FEB - 4 201

Re: K102753

Trade/Device Name: Turbo Temp 3 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Material Regulatory Class: II Product Code: EBG Dated: January 5, 2011 Received: January 31, 2011

## Dear Ms. Tilton:

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 affective your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In 1 addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Tilton

Enclosure

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.

Nh 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

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## Indications for Use

510(k) Number (if known): K | 02753

Device Name: Turbol) Temp 3

Indications For Use:

Turbo Temp 3 is a syringe able
acrylic provisional composite used
for temporary crown and bridge
placement.

Prescription Use (Part 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 Exaluation (ODE)

Susan Kuper

(Division Sign-Off) (Division Sign-Uff)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antool, Dental Devices

K162753
510(k) Number: Page 1 of