← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K052409 # SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL (K052409) _Sultan Chemists, Inc. · ELW · Oct 20, 2005 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K052409 ## Device Facts - **Applicant:** Sultan Chemists, Inc. - **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md) - **Decision Date:** Oct 20, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ ## 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ ## Statement of Indications For Use Page l l of of of l ## 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K052409](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K052409) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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