ISO FUNCTIONAL

K022430 · GC America, Inc. · ELW · Oct 18, 2002 · Dental

Device Facts

• Record ID: K022430
• Device Name: ISO FUNCTIONAL
• Applicant: GC America, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

ISO Functional is used as a rebasing and relining impression material.

Device Story

ISO Functional is a dental impression material used by dental professionals for rebasing and relining procedures. It functions as a moldable medium to capture the anatomy of the oral cavity, facilitating the fabrication of dental prosthetics. The material is applied by a clinician in a dental office setting. It provides a negative imprint of oral tissues, which is used to create accurate models for prosthetic adjustments or replacements, ultimately benefiting the patient by ensuring proper fit and function of dental appliances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impression material for dental use. Class II device. No specific material composition, sensing, or software characteristics described.

Indications for Use

Indicated for use as a dental impression material for rebasing and relining 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 1 8 2002

Re: K022430

Trade/Device Name: ISO Functional Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: 76 ELW Dated: July 11, 2002 Received: July 25, 2002

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.

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.

Image /page/0/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is in black and white.

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Page 2 - Mr. Joritz

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy 1 . Ulatowski 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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510(k) Number (if known): ISO Functional Device Name: Indications For Use:

ISO I unctional is used as a rebasing and relining impression material.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Presc iption Use (Per 11 CFR 801.109

OR

Over-The-Counter Use

Susan Runne

(Optional Format 1-2-96)

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

510(k) Number: K022430