TORPICALGIN

K043131 · Zhermack S.P.A. · ELW · Dec 15, 2004 · Dental

Device Facts

• Record ID: K043131
• Device Name: TORPICALGIN
• Applicant: Zhermack S.P.A.
• Product Code: ELW · Dental
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

Device Story

Tropicalgin is a dental impression material; applied to preformed impression trays; used by dental professionals to capture anatomical impressions of patient teeth. Material sets to form a negative mold; used to create positive stone or plaster models for study or fabrication of dental prosthetics (inlays, dentures). Device facilitates clinical restorative workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental impression material; alginate-based; supplied as a powder for mixing with water; manual application via preformed impression tray; non-electronic; no software.

Indications for Use

Indicated for use as a dental impression material to reproduce tooth structure for study models and the fabrication of restorative prosthetic devices like inlays and dentures in dental patients.

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

DEC 1 5 2004

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

Re: K043131

Trade/Device Names: Tropicalgin Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 09, 2004 Received: November 12, 2004

Dear Mr. Shipps:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bookermined the device is substantially equivalent (for the indications for referenced abo re and nave 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 provisions in May 20, 1978, the enablems with the provisions of the Federal Food, Drug, and Cosmetic nat (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 bonufacturing 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 n your de 10 rise 10 such additional controls. Existing major regulations affecting your device can be may be subject to same and 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 - Mr. Gerald W. Shipps

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 (2) CFR Park 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 and that 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, primits 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 vours,

Chiu S. Lin, Ph.D.

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): TROPICALGIN Device Name: Indications for Use:

Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 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 Rums

(Division Sign-Off) production Gigh-Old)
Division of Anesthesiology, General Hospital, and then of Anesthesiology, Gene

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________