(76 days)
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Not Found
No
The summary describes a dental impression material, which is a physical substance, and contains no mention of software, algorithms, or any terms related to AI/ML.
No
The device is described as an impression material used to reproduce the structure of teeth and gums, which is a diagnostic purpose, not a therapeutic one. It does not treat or prevent a disease or condition.
No
The "Intended Use / Indications for Use" states that the material is used to "reproduce the structure of a patient's teeth and gums," which is for making an impression, not for diagnosing a medical condition.
No
The device is described as an "Impression Material," which is a physical substance used to create a mold. This is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reproduce the structure of a patient's teeth and gums for dental impressions. This is a physical process used for creating models, not for performing tests on samples taken from the body to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material used to create a physical mold of anatomical structures within the mouth. This falls under the category of a dental impression material, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
S & C Hydro Vinyl Polysiloxane Impression Material is intended to be placed into a syringe for delivery around a tooth or on a preformed impression tray for placement in the mouth, and used to reproduce the structure of a patient's teeth and gums.
Product codes
ELW
Device Description
S & C Hydro Vinyl Polysiloxane Impression Material
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
patient's teeth and gums
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three lines representing the eagle's head and neck. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 1 2001
Dr. Christian Bottcher Regulatory Compliance Officer S & C Polymer GmbH Silicon-Und Composite Spezialitate Robert-Bosch-Strabe 5 Elmshorn, GERMANY
Re: K012767
Trade/Device Name: S & C Hydro Vinyl Polysiloxane Impression Material Regulation Number: 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: August 14, 2001 Received: August 17, 2001
Dear Dr. Bottcher:
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 your 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 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
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Page 2 - Dr. Bottcher
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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9. Statement of Indications for Use
NOV 0 1 2001
510(k) Number (if known):
Device Name:
Indications for Use:
S & C Hydro Vinyl Polysiloxane Impression Material
S & C Hydro Vinyl Polysiloxane Impression Material is intended to be placed into a syringe for delivery around a tooth or on a preformed impression tray for placement in the mouth, and used to reproduce the structure of a patient's teeth and gums.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Roon
Firm Sign-Off) sion of Dental, Infection Control, Ceneral Hospita Com Number .
Prescription Use:
or