(38 days)
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.
Here's an analysis of the provided information regarding the A-SILICONE device, focusing on acceptance criteria and the study proving it:
The provided document is a 510(k) summary for a dental impression material named A-SILICONE. A 510(k) submission primarily demonstrates substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving acceptance against a set of performance criteria through a traditional clinical study with defined ground truth and expert adjudication in the same way a diagnostic AI might be evaluated.
Therefore, the answers below will reflect this context, explaining that the "acceptance criteria" here are essentially the properties and performance parameters that need to be comparable to predicate devices for a favorable substantial equivalence determination. The "study" for this type of device is the testing conducted to measure these properties against established standards or predicate device performance.
Acceptance Criteria and Study for A-SILICONE
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a dental impression material, the "acceptance criteria" are the physical and chemical properties that demonstrate it is as safe and effective as predicate devices. The reported device performance is measured against these properties.
| Property | Acceptance Criteria (Implied by Predicate & ISO Standards) | Reported Device Performance (A-SILICONE) |
|---|---|---|
| Consistency, ISO 4823 | Type-specific (e.g., heavy body type 0, light body type 3) | Matches ISO 4823 types for each viscosity |
| Color | Distinct colors for different viscosities | Putty: light green, Heavy: turquoise, Medium: lilac, Light: pink |
| Working time including mixing | Clinically acceptable range | 45 seconds to one minute |
| Time in the mouth | Clinically acceptable range | two minutes |
| Total setting time, minimum | Clinically acceptable range | 2 minutes - 45 seconds |
| Strain in compression, % | Typically low (99%) to ensure impression accuracy | Putty: >99.4, Heavy: >99.4, Medium: >99.6, Light: >99.6 |
| Linear dimensional change, %, max | Low ( |
§ 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).