(106 days)
Not Found
No
The device description and performance studies focus on the physical properties of impression materials, with no mention of AI or ML.
No.
The device is used to take impressions of oral tissues for the preparation of orthodontic prostheses and to create study models, not to directly treat a condition. Adherence to ISO 1563:1990 (which specifies requirements for alginate impression materials) also supports its classification as a diagnostic/material device rather than a therapeutic one.
No
The device is an impression material used for taking impressions of oral tissues, which are then used to create orthodontic prostheses and study models. Its purpose is to physically record the shape of oral tissues, not to diagnose a condition or disease.
No
The device description explicitly states the materials consist of "powders which, when mixed with water, form a setting gel," indicating a physical material, 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 take impressions of oral tissues for the preparation of orthodontic prostheses and study models. 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 device is a material that forms a gel for taking impressions. This aligns with the intended use and does not describe a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device is used to create a physical representation of oral tissues.
N/A
Intended Use / Indications for Use
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
Product codes
Not Found
Device Description
These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.
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 tissues
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Non-clinical tests are in accordance with ISO 1563:1990 and include tests for working time, setting characteristics, strength, flexibility, compatibility with gypsum casting materials and pH. In all the above tests the subject product is at least comparable to the predicate product. The subject material is faster setting and stronger when set. Both these enhanced attributes are clear advantages in clinical use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 word "WHITE" in a stylized, bold font. The letters are thick and slightly slanted, giving the word a dynamic appearance. The overall impression is one of strength and modernity.
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PAGE 21 OF 33
APR - 4 1997
PREMARKET NOTIFICATION
510(k) SUMMARY (continued)
TRADE NAMES:
Super-Dent Alginate, Normal set
Super-Dent Alginate, Fast set
Super-Dent Super DeLuxe Dustless Alginate, Normal set
Super-Dent Super DeLuxe Dustless Alginate, Fast set
Alginate impression material COMMON NAME:
Material, All, Impression CLASSIFICATION NAME:
Dental Alginate Impression Material; EQUIVALENT TO: 510(k) number K883842
Marketed by Dentsply as JELTRATE in fast and regular set versions
DESCRIPTION :
These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.
INTENDED USE:
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
TECHNOLOGICAL CHARACTERISTICS:
Both materials are powders which, when mixed with water, create a setting gel which is applied to the oral tissues in a rigid tray to create an impression of such tissues. The materials set after mixing by virtue of the reaction between an alginate material and calcium ions to form insoluble calcium alginate. The set materials are compatible with oral tissues and the set is chemically controlled in the interests of patient comfort. The set materials are sufficiently flexible to remove from the mouth readily yet strong enough to withstand subsequent handling. Both materials are compatible with dental plaster and stone model materials.
1
Image /page/1/Picture/0 description: The image shows the word "WHITE" in a stylized, bold, and slightly slanted font. The letters are all capitalized and appear to be interconnected or overlapping in certain areas, giving the word a unique and somewhat abstract appearance. The color of the text is black, contrasting with what is presumably a white or light-colored background. The overall design is simple yet eye-catching, with a focus on the visual impact of the word itself.
PAGE 22 OF 33
PREMARKET NOTIFICATION
510(k) SUMMARY (continued)
NON-CLINICAL DATA:
Non-clinical tests are in accordance with ISO 1563:1990 and include tests for working time, setting characteristics, strength, flexibility, compatibility with gypsum casting materials and pH.
In all the above tests the subject product is at least comparable to the predicate product.
The subject material is faster setting and stronger when set. Both these enhanced attributes are clear advantages in clinical use.
CLINICAL DATA:
There is none applicable
CONCLUSIONS :
The data summarised above indicates that the subject device is substantially equivalent to the predicate device.
Any differences in performance result in improvements which reduce the setting time in the interests of patient comfort and increase the compressive strength improving the resistance to damage in handling of the impression.