(43 days)
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Not Found
No
The summary describes a dental impression material (alginate) and does not mention any software, image processing, or AI/ML terms.
No
The device is used to create an impression of a person's mouth/teeth for diagnostic purposes (creating a cast), not to treat or alleviate a medical condition.
No
The device is used to create an impression of a patient's mouth/teeth for the purpose of making a cast, which is a manufacturing or fabrication step, not a diagnostic one. It doesn't analyze or interpret any biological data to provide insights into a patient's health condition.
No
The device description clearly states "Kromatica Color Changing Alginate," which is a physical material used for dental impressions, 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 create a physical impression of a patient's mouth/teeth for the purpose of making a cast. This is a mechanical process for creating a physical model, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as "Kromatica Color Changing Alginate," which is a material used for taking impressions.
- 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 analytes
- Providing diagnostic or monitoring information
The device is a material used in a dental procedure to create a physical model, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.
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
Mouth/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul L. Saxton Manaqer Matech, Incorporated 13010 San Fernando Road Sylmar, California 91342
FEB 1 2 1998
K974894 Re : Kromatica Color Changing Alginate Trade Name: Regulatory Class: II Product Code: ELW December 12, 1997 Dated: Received: December 31, 1997
Dear Mr. Saxton:
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 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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) 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
1
Page 2 - Mr. Saxton
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or 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 finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other gener 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Kromatica Alginate Impression Material
Matech, Inc. 510 (k) Request. Indications For Use:
The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.
Sincerely,
Paul L. Saxton
Manager Matech, Inc. 13010 San Fernando Road Sylmar, CA 91342
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Division Chief)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)