SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL

K052409 · Sultan Chemists, Inc. · ELW · Oct 20, 2005 · Dental

Device Facts

• Record ID: K052409
• Device Name: SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
• Applicant: Sultan Chemists, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Silgimix™ is indicated for use as a dental impression material. The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.

Device Story

Silgimix is a dental impression material used by dental professionals to capture anatomical structures of the oral cavity. It is applied to a dental tray and inserted into the patient's mouth to create a negative mold. Once set, the material provides a detailed impression used for fabricating study models, orthodontic models, counter impressions, partial dentures, and temporary crowns. The device assists clinicians in diagnostic planning and restorative procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Impression material classified under 21 CFR 872.3660 (Product Code: ELW). Physical properties consistent with standard dental impression materials used for study models and temporary restorations.

Indications for Use

Indicated for dental patients requiring impressions for study models, orthodontic models, counter impressions, partial denture impressions, and temporary crown fabrication.

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 and Human Services. The logo features a stylized depiction of an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052409

Trade/Device Name: Silgimix® Alginate Replacement Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 28, 2005 Received: September 13, 2005

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviews. Jour secured the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce use surfed in the encreates) were ment date of the Medical Device Amendments, or to devices that provision in the provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic nu v och roendome approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the act include requirements for annual registration, listing of devices, good controller provise , 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 device to such additional controls. Existing major regulations affecting your device can be may of subject to sach acade 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 - Clark Smith, DDS

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s Issualled of a vaces in a succession in other requirements of the Act or that FDA nas made a decemination max your cell be other Federal agencies. You must comply with ally Federal Statutes and regulations and limited to: registration and listing (21 CFR Part 807); all the Act STEQuiltents, morading, but normalize requirements as set forth in the quality labeling (21 CFR Part 801), good manalation.mage and if applicable, the electronic product radiation systems (QB) regards (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) I his letter whil anow you to begin manothy of substantial equivalence of your device to a legally premits toutineation: "The I Driving of bation 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 If you desire specific acries in 1540) 276-0115. Also, please note the regulation entitled, Contact the Office of Comphance at (210) 278 of 2019 (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Susan Russo

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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## Statement of Indications For Use

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## 11052409 510(k) Number:

Device Name: _________________________________________________________________________________________________________________________________________________________________

Silgimix™ is indicated for use as a dental impression material. Indications For Use: The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.

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

Or

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use __

Suxer Rurases

(Civision Sign-Off) ( Division of Anesthesionogy, Dental Devices

510(k) Number: K052409