(53 days)
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No
The device description focuses on the color-changing properties of the alginate material based on chemical reactions, not on any computational or learning-based processes. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
The device is described as an impression material used to reproduce the structure of teeth and gums for study models and production of restorative prosthetic devices, not to directly treat a medical condition.
No
This device is an impression material used to create models of teeth and gums, not to diagnose a medical condition.
No
The device description clearly describes a physical material (alginate impression) that changes color, indicating it is a hardware-based product, 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 reproduce the structure of teeth and gums to create models for study and production of restorative prosthetic devices. This is a physical process for creating a mold, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a material used for taking impressions, not for analyzing biological samples. The color changes are indicators of the material's physical state, not diagnostic markers.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a dental impression material, which is not considered an IVD.
N/A
Intended Use / Indications for Use
The product is intended for use as impression material as defined in §872.3660 of CFR 21, "to reproduce the structure of a patient's teeth and gums ... to provide models for study and for production of restorative prosthetic devices," etc.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
TriPhasix Chromatic Alginate may be described as a vanilla flavored alginate impression which changes color from violet to pink to white to indicate completion of mixing, appropriate consistency for tray loading and appropriate consistency for impressioning, respectively. Slight alteration of water-to-powder ratios will deliver "heavy", "medium", or "light" body mixtures as preferred by the user.
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 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): 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
SEP - 6 1996
9627
510(k) SUMMARY
Submitter:
Nelson J. Gendusa, DDS Director of Research Parkell Products, Inc. 155 Schmitt Blvd. Farmingdale, NY 11735 TEL: 516-249-1134 FAX: 516-249-1242
Contact:
Same as above
Date of Submission: July 9, 1996
Trade Name:
Common Name: Alginate Impression Material
Classification Name:
Impression Material (21 CFR §872.3660)
Parkell TriPhasix Chromatic Alginate
Equivalence:
Chromaclone Color Changing Alginate Orthalgenat Impression Material Algidenco and Algiprint Impress Material Dental Alginate Impression Material Proof Alginate Impression Material Cutter-Jel Alginate Impression Material
Description and Intended Use:
TriPhasix Chromatic Alginate may be described as a vanilla flavored alginate impression which changes color from violet to pink to white to indicate completion of mixing, appropriate consistency for tray loading and appropriate consistency for impressioning, respectively. Slight alteration of water-to-powder ratios will deliver "heavy", "medium", or "light" body mixtures as preferred by the user. The product is intended for use as impression material as defined in §872.3660 of CFR 21, "to reproduce the structure of a patient's teeth and gums ... to provide models for study and for production of restorative prosthetic devices," etc.
The above-cited material complies with ISO 1563/1990 FOR ALGINATE. It contains no hazardous materials. Mixing time is 45 seconds. Total working time is 2 minutes 25 seconds. It is compatible with dental model gypsum and reproduces 50 micron detail.