(57 days)
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No
The summary describes a physical dental impression material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
The device is used to make dental impressions for plaster models, not to treat a disease or condition.
No
The device is used to make dental impressions, which are then used to create plaster models of teeth. Its function is to create a physical mold, not to diagnose a condition or disease.
No
The device description clearly states that Neocolloid and Orthoprint are "alginate dental impression materials," which are physical substances used to create impressions. This indicates a hardware component (the material itself) is central to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to make dental impressions for creating plaster models of teeth. This is a physical process for creating a mold, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is an alginate dental impression material. This is a material used for molding, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or analytical methods
Therefore, Neocolloid and Orthoprint, as described, are dental materials used for creating physical impressions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Product codes
ELW
Device Description
Neocolloid and Orthoprint are alginate dental impression materials.
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
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.)
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ZHERMACK S.p.A. ·C/O Evan G. Dick, Ph.D E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
MAY 21 1998
Re : K981091 Neocolloid, Orthoprint Trade Name: Requlatory Class: II Product Code: ELW Dated: March 25, 1998 March 25, 1998 Received:
Dear Dr. Dick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Page 320) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Dick
through 542 of the Act for devices under the Electronic Chrough 542 Or che not 10- 10- 10- 10- 10- other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your six (i) privalence of your device to a legally marketed predicate device results in a classification for your marketed predice and thus, 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 809.10 for in regulation (== (============================================================================================================================================================= Additionally, for questions on Compliance at (301) 594-4692. compreation 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... .
2
INDICATIONS FOR USE STATEMENT
510(k) Number:
Neocolloid and Orthoprint Device Names:
Indications For Use:
, -
Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions.
The resulting impressions are used to make plaster models of the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number | K981091 |
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--------------- | --------- |
Prescription Use | Over-The-Counter Use |
---|---|
(per 21 CFR 801.109) | OR |
(Optional Format 1-2-96)