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510(k) Data Aggregation
(344 days)
Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.
| Performance Characteristic | Accusil Dental Impression Materials (Reported Performance) | Acceptance Criteria (Implicit from ISO standards and comparison with predicate/references) |
|---|---|---|
| Working/Processing Time | 40-150 sec | Similar to predicate (90 sec) and reference devices (35-120 sec). |
| Setting time/Time in the mouth | 60-300 sec | Similar to predicate (90 sec) and reference devices (120-330 sec). |
| Hardness | 63-70 Shore A | Similar to predicate (46-70 Shore A) and reference devices (42-75 Shore A). |
| Working Humidity | 50% | Matches predicate (50%). |
| Dimensional Accuracy | 99.9%-99.2% | Similar to predicate (99.9%-99.2%) and reference devices (98%-99.9%). |
| Stability (Linear Dimensional Change) |
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(246 days)
StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.
StoneBite® is indicated for:
- bite registrations
- I key for intraoral registration
StoneBite® scan is indicated for:
- i bite registrations
- key for intraoral registration
- . optical collection of data in CAD/CAM/CIM systems
StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.
StoneBite and StoneBite scan are vinyl polysiloxane based materials.
StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.
The document describes the non-clinical performance testing for dental impression materials, specifically StoneBite and StoneBite scan. This is not medical AI device and therefore does not contain any of information requested.
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