(49 days)
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No
The summary describes a dental impression material and provides no information suggesting the use of AI or ML.
No
The device is described as a dental impression material for taking impressions, which is a diagnostic or procedural tool, not a device used for treating a disease or condition.
No
Explanation: The device, Silgimix™, is described as a dental impression material used for taking impressions. Its stated uses (study models, orthodontic models, etc.) are for creating physical models of anatomical structures, not for diagnosing diseases or conditions.
No
The intended use clearly describes a dental impression material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Silgimix™ is a "dental impression material" used for taking impressions for various dental models and temporary crowns. This is a physical process of creating a mold of anatomical structures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information about a patient's health status, disease, or condition based on sample analysis.
Dental impression materials are considered medical devices, but they fall under a different regulatory category than IVDs. They are used to create a physical representation of a patient's anatomy, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
SilgimixTM 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.
Product codes
ELW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).
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