(20 days)
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No
The device description details a color-changing alginate material, which is a chemical reaction, not an AI/ML process. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is an impression material used for diagnostic and model construction purposes, not for treating any condition or disease.
No
The device, Xantalgin Crono, is an impression material used to create a physical model of the oral cavity. It is not used to identify or characterize a disease or condition, which is the function of a diagnostic device. Its purpose is to facilitate the construction of dental appliances or study models.
No
The device is a dental impression material, which is a physical substance, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Xantalgin Crono is to take impressions of the oral cavity for the purpose of creating a physical model (gypsum cast). This model is used for various dental procedures like making study models, individual trays, etc. This is a physical process for creating a replica, not a diagnostic test performed on a sample from the body.
- Device Description: The description details the material composition (alginate) and its color-changing properties, which are related to the handling and setting of the material. It does not describe any components or processes for analyzing biological samples.
- 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. Xantalgin Crono does not perform any such analysis.
Therefore, Xantalgin Crono is a dental impression material, which is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Xantalgin Crono has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Xantalgin Crono is a dental impression material based on alginate. It has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.
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
oral cavity
Indicated Patient Age Range
Not Found
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).
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 stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2001
Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmenjansweg 19 P.O. Box 852 Haarlem (Holland) NETHERLANDS
Re: K013336
Trade/Device Name: Xantaglin Crono Regulation Number: 872.3660 Regulation Name: Alginate Impression Material Regulatory Class: II Product Code: ELW Dated: October 8, 2001 Received: October 9, 2001
Dear Mr. Woortman:
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 - Woortman
mean that FDA has made a determination that your device complies with other requirements modi that I DA mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I outstal statest requirements, including, but not limited to: registration I ou must compry with an are rise Jog (21 CFR Part 801); good manufacturing practice alle listing (21 CF RT rat 007), acclines (QS) regulation (21 CFR Part 820); and if requirences as set form in als quality ijo 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 I his letter will anow you to begin in the may of substantial equivalence of your device to 310(k) promation nounce 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 If you desire up con of 2001 of r in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Collightance itse, 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 nonicallor (21 OF ICP of the Division of Small Manufacturers, International and the Act may be counter 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,
A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN): KO/3336
DEVICE NAME: Xantalgin Crono Alginate Impression Materials
INDICATIONS FOR USE:
Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Xantalgin Crono has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseV (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Sudar Runner
(Division Sign-Off) (Division Sign-Onn)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Dontonital Devic 510(k) Number -