HYDRORISE AND HYDROSYSTEM

K083739 · Zhermack S.P.A. · ELW · Mar 26, 2009 · Dental

Device Facts

• Record ID: K083739
• Device Name: HYDRORISE AND HYDROSYSTEM
• Applicant: Zhermack S.P.A.
• Product Code: ELW · Dental
• Decision Date: Mar 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

HYDRORISE is 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. HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension before applying traditional dental impression material.

Device Story

HYDRORISE is a two-component polyvinylsiloxane (VPS) dental impression material; HYDROSYSTEM is a surface wetting agent. Used by dentists/dental professionals in clinical settings to capture accurate anatomical impressions of teeth and gums. HYDRORISE is loaded into impression trays; HYDROSYSTEM is applied to substrates (teeth, ceramics, composites) to reduce surface tension and improve wetting before impression material placement. Output is a physical dental impression used for fabrication of dental prosthetics or diagnostic models. Benefits include high-fidelity reproduction of oral structures, facilitating precise dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-component (base/catalyst) polyvinylsiloxane (VPS) impression material. Accessory wetting agent (HYDROSYSTEM) reduces surface tension. Class II device (21 CFR 872.3660).

Indications for Use

Indicated for dental patients requiring impressions of teeth and gums for restorative or diagnostic purposes. HYDROSYSTEM is indicated for surface wetting of tooth preparations, ceramics, composites, and metal core build-ups prior to impression material application.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and a circular seal around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the top half of the seal.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 6 2009

Zhermack S.P.A. C/o Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

K083739 Re:

> Trade/Device Name: HYDRORISE and HYDROSYSTEM Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 17, 2009 Received: March 19, 2009

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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Page 2 - Mr. 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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sincerely yours,

Sutte Y. Michcen Omd

Ginette Y. Michaud, M.D. Acting 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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2 INDICATIONS FOR USE 510(k) Number (if known):

Device Name: HYDRORISE and HYDROSYSTEM

Indications for Use:

HYDRORISE is conventional ପ୍ର 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.

HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension beliore applying traditional dental impression material.

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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Infection Control, Dental Devices 510(k) Number:

HYDRORISE

Rev. 0 November, 03 2008