FREEALGIN

K070700 · Zhermack S.P.A. · ELW · Apr 25, 2007 · Dental

Device Facts

• Record ID: K070700
• Device Name: FREEALGIN
• Applicant: Zhermack S.P.A.
• Product Code: ELW · Dental
• Decision Date: Apr 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient`s teeth and gums.

Device Story

Freealgin is a two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material. It is applied to a preformed dental impression tray by a dental professional. The material captures the physical structure of a patient's teeth and gums to create a negative mold. This mold is used by dentists to fabricate dental restorations or appliances. The device is used in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material. Formulated for use with preformed impression trays. Class II medical device.

Indications for Use

Indicated for use as a dental impression material to reproduce the structure of teeth and gums in patients requiring dental impressions.

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/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zhermack SpA C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend. Oregon 97702

APR 2 5 2007

Re: K070700

Trade/Device Name: Freealgin Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 12, 2007 Received: March 13, 2007

Dear Mr. Shipps:

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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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" (21 CFR 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/industry/support/index.html.

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Sincerely yours,

Susan Rumor

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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Image /page/2/Picture/0 description: The image shows the logo for "Zhermack BEYOND INNOVATION". The logo consists of the company name in bold, stylized letters, with the tagline "BEYOND INNOVATION" underneath. To the right of the text are two parallelogram shapes, arranged diagonally, adding a visual element to the logo.

INDICATIONS FOR USE

510(k) Number (if known):

2

Device Name: FREEALGIN

Use: FREEALGIN is a conventional Indications for two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient`s teeth and gums.

Prescription Use \

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Chis Or

Sion of Aneathanicialogy, General Hospital, Jon Control, Demal Devices

:x(k) Number. k φφφφφ

FREEALGIN Rev. 0 February, 26 2007