GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL

K030414 · Sultan Chemists, Inc. · ELW · Apr 9, 2003 · Dental

Device Facts

• Record ID: K030414
• Device Name: GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
• Applicant: Sultan Chemists, Inc.
• Product Code: ELW · Dental
• Decision Date: Apr 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Device Story

Sultan Genie Ultra Hydrophilic Impression Material is a dental impression material used by dental professionals. The material is supplied in an automatic mixing cartridge system; it is dispensed into dental impression trays (metal or plastic) and placed intra-orally to capture the anatomy of teeth and gums. The resulting impression is used to create physical models for study or the fabrication of dental prosthetics. The device functions as a physical molding agent to record oral geometry.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrophilic impression material; supplied in automatic mixing cartridge system; compatible with standard metal or plastic dental impression trays.

Indications for Use

Indicated for use as a dental impression material to reproduce intra-oral structures (teeth and gums) for study models or fabrication of prosthetic devices.

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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APR 0 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Clark Smith Senior Vice President Sultan Chemists, Incorporated 85 West Forest Avenue Englewood, New Jersey 07631

Re: K030414

Trade/Device Name: Sultan Genie™ Ultra Hydrophilic Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: January 11, 2003 Received: February 07, 2003

Dear Dr. Smith:

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 vour 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 vour 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 - Dr. Clark Smith

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]. 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) you may obtain. 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,

Susan Runser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Statement of Indications For Use

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**510(k) Number:** K030414

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _

Kein Muluy for NSP

Or

v. General Hospital

510(k) Number:***_***_