HYDROCOLOR 5

K102739 · Cascades Device Consulting Associates · ELW · Dec 8, 2010 · Dental

Device Facts

• Record ID: K102739
• Device Name: HYDROCOLOR 5
• Applicant: Cascades Device Consulting Associates
• Product Code: ELW · Dental
• Decision Date: Dec 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

HYDROCOLOR 5 is a conventional alginate 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

HYDROCOLOR 5 is a conventional alginate dental impression material. Used by dental professionals; placed on preformed impression trays to capture anatomical structure of patient teeth. Material sets to form a negative mold; used to create positive dental models for study or fabrication of restorative prosthetics like inlays and dentures. Benefits include accurate reproduction of oral structures for clinical planning and prosthetic manufacturing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Conventional alginate-based dental impression material. Supplied as a powder for mixing with water. Formulated for use with standard dental impression trays. No electronic or software components.

Indications for Use

Indicated for use as a dental impression material to reproduce tooth structure and create models for study or restorative prosthetic devices (inlays, dentures) 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

DEC - 8 2010

Re: K102739

Trade/Device Name: HYDROCOLOR 5 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 21, 2010 Received: September 22, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Rusnov

Anthony D. Watson, B.S., M.S., M.B.A. 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): | K102739 |
|---------------------------|---------|
|---------------------------|---------|

2 INDICATIONS FOR USE

DEC - 8 2010

Device Name: HYDROCOLOR 5

Indications for Use:

HYDROCOLOR 5 is a conventional alginate 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.

Prescription Use

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 807 Subpart

(Part 21 CFR 801 Subpart D) ్ర

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Pusner

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

510(k) Number. K102731

HYDROCOLOR 5 Rev. 0 September 21, 2010