FUSION FAST

K043471 · GC America, Inc. · ELW · Jan 27, 2005 · Dental

Device Facts

• Record ID: K043471
• Device Name: FUSION FAST
• Applicant: GC America, Inc.
• Product Code: ELW · Dental
• Decision Date: Jan 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.

Device Story

Fusion Fast Set is a vinylpolysiloxane (VPS) impression material used by dental professionals in clinical settings. The material is applied intra-orally to capture the anatomy of teeth and surrounding tissues. It functions as a dental impression material to create accurate molds for restorative or prosthetic dental work. The device is a physical material, not an electronic or software-based system.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vinylpolysiloxane (VPS) impression material. Class II dental impression material (21 CFR 872.3660).

Indications for Use

Indicated for use as a vinylpolysiloxane impression material for taking intra-oral dental impressions in patients requiring dental restorative or prosthetic procedures.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure or a flowing design. The symbol is positioned in the center of the circle.

JAN 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry L. Joritz Director, Regulatory Affairs & Ouality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K043471

Trade/Device Names: Fusion™ Fast Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: December 14, 2004 Received: December 24, 2004

Dear Ms. Joritz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Terry L. Joritz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu S. Lin, PhD

Chiu S. Lin, PhD 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

510(k) Number (if known): _ K04347)

Device Name:

FUSION FAST SET

Indications for Use:

This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.

Prescription Use (21 CFR Part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

ிvision Sign-Off) Unision of Anesthesiology, General Hospital, Infection Control. Dental Devices

210(k) Number: Y04347

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