(12 days)
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Not Found
No
The summary describes a dental impression material, which is a physical substance, and there is no mention of software, algorithms, or any terms related to AI/ML.
No
The device is an impression material used to reproduce the structure of teeth and gums, which is a diagnostic or procedural step, not a treatment itself.
No
Explanation: The device is a dental impression material used to reproduce the structure of teeth and gums. It is not used to identify or determine the nature of a disease or condition, which is the function of a diagnostic device.
No
The device is described as a dental impression material, which is a physical substance, not software.
Based on the provided information, Zhermack ZETAPLUS SOFT 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 using a dental impression material. This is a physical process for creating a mold, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Purpose: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. ZETAPLUS SOFT does not perform any such analysis or provide diagnostic information.
- Physical Material: It is described as a "dental impression material," which is a physical substance used to create a mold.
Therefore, Zhermack ZETAPLUS SOFT falls under the category of a medical device, specifically a dental device, but not an IVD.
N/A
Intended Use / Indications for Use
Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression).
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 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)
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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
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Zhermack S. P. A. C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K024041
Trade/Device Name: Zetaplus Soft Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 2, 2002 Received: December 6. 2002
Dear Mr. Shipps:
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.
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.Page 2 - Mr. 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 (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). 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 vours.
Pelloux Cucute fils
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number:
ZETAPLUS SOFT
240
Device Name:
Indications for Use:
Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Surser Rume
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K093211