(33 days)
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No
The device is a dental impression material, which is a physical substance, and the summary contains no mention of AI or ML.
No
The device is a dental impression material used to reproduce teeth structure for models, not to treat a disease or condition.
No
Explanation: The device, Zhermack TROPICALGIN, is a dental impression material used to reproduce the structure of a patient's teeth and provide models for study and production of restorative prosthetic devices. It does not perform any diagnostic function; its purpose is for physical modeling and production, not for identifying diseases or conditions.
No
The device is described as a "dental impression material," which is a physical substance used to create a mold. This is a hardware component, not software.
Based on the provided information, Zhermack TROPICALGIN is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of Zhermack TROPICALGIN is to reproduce the structure of a patient's teeth by taking an impression directly in the mouth. It is then used to create models for study and the production of dental devices.
- The process described is a direct interaction with the patient's anatomy (teeth) to create a physical mold. This is a clinical procedure, not an in vitro test performed on a biological sample.
Therefore, Zhermack TROPICALGIN falls under the category of a dental device used for taking impressions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
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
patient's teeth
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Zhermack SpA C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K043131
Trade/Device Names: Tropicalgin Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 09, 2004 Received: November 12, 2004
Dear Mr. Shipps:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bookermined the device is substantially equivalent (for the indications for referenced abo re and nave 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 provisions in May 20, 1978, the enablems with the provisions of the Federal Food, Drug, and Cosmetic nat (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 bonufacturing 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 n your de 10 rise 10 such additional controls. Existing major regulations affecting your device can be may be subject to same and 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 - Mr. Gerald W. Shipps
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 (2) CFR Park 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 and that 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, primits 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 (240) 276-0115. 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 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 vours,
Chiu S. Lin, Ph.D.
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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Indications for Use 510(k) Number (if known): TROPICALGIN Device Name: Indications for Use:
Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rums
(Division Sign-Off) production Gigh-Old)
Division of Anesthesiology, General Hospital, and then of Anesthesiology, Gene
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510(k) Number: _______________________________________________________________________________________________________________________________________________________________