(106 days)
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.
These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.
This 510(k) premarket notification for the Super-Dent Alginate impression material details non-clinical testing against ISO 1563:1990. However, it's important to note that no clinical data was applicable or presented for this submission. The device is considered substantially equivalent to a predicate device (JELTRATE, K883842) based solely on non-clinical performance.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 1563:1990) | Reported Device Performance (Super-Dent Alginate) | Passes/Fails |
|---|---|---|
| Working Time (specific standard not provided) | Comparable to predicate product | N/A (implied pass) |
| Setting Characteristics (specific standard not provided) | Faster setting than predicate product | N/A (implied pass, and an improvement) |
| Strength (specific standard not provided) | Stronger when set than predicate product | N/A (implied pass, and an improvement) |
| Flexibility (specific standard not provided) | Comparable to predicate product | N/A (implied pass) |
| Compatibility with Gypsum Casting Materials (specific standard not provided) | Compatible with dental plaster and stone model materials, comparable to predicate | N/A (implied pass) |
| pH (specific standard not provided) | Comparable to predicate product | N/A (implied pass) |
Notes on Acceptance Criteria: The document states that "Non-clinical tests are in accordance with ISO 1563:1990." This ISO standard defines requirements for alginate impression materials. While the specific numerical acceptance criteria for each test (e.g., minimum working time, minimum compressive strength) are not explicitly stated in the provided text, the submission implies that the Super-Dent Alginate met or exceeded these criteria by stating it was "at least comparable to the predicate product" or "faster setting and stronger when set."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Non-clinical tests" without detailing the number of samples used for each test.
- Data Provenance: The tests were non-clinical, likely conducted in a laboratory setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the evaluation was based on non-clinical laboratory testing against an ISO standard, not on expert-adjudicated clinical data requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
- This question is not applicable as there was no clinical test set requiring adjudication. The evaluation was based on objective measurements in a laboratory setting against an ISO standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- This question is not applicable. This premarket notification is for a dental impression material, not an AI-powered diagnostic or assistive device. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This premarket notification is for a physical medical device (dental impression material), not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was established by objective physical and chemical measurements as defined and specified by the ISO 1563:1990 standard for alginate impression materials. This standard sets technical specifications for characteristics like working time, setting time, strength, flexibility, etc.
8. The Sample Size for the Training Set
- This question is not applicable. This submission describes laboratory testing of a physical product, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the reasons stated in point 8.
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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.
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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.
§ 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).