(60 days)
Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions
Chemi-SiL Bite-Blu - Impression of the occlusal surface
Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.
This document is a 510(k) Premarket Notification from B&E Korea Co., Ltd. for their dental impression materials, Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu. The key focus of this notification is to demonstrate substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
The primary method for demonstrating acceptance criteria and performance is through non-clinical testing based on recognized international standards, specifically ISO 4823 for impression materials and ISO 10993 for biocompatibility. The acceptance criteria are the performance requirements specified by these standards and the reported values of the predicate devices. The device performance is the measured performance of the Chemi-SiL products.
Here's a table summarizing the acceptance criteria (defined by ISO standards and predicate device performance) and the reported device performance for Chemi-SiL. Note that the document compares the subject devices to two different predicate devices based on their specific uses.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO Standard / Predicate Device) | Reported Device Performance (Chemi-SiL) | Discussion/Justification (from document) |
|---|---|---|---|
| For Chemi-SiL (HB, MB, LB, LBS) vs. Vonflex STM (K152615) | |||
| Working time | Vonflex STM: 2'15" (Heavy, normal); 1'30" (Heavy, Fast); 2'30" (Light, normal); 1'30" (Light, Fast) | ||
| [ISO 4823:2021 7.3] suggested value of the manufacturer | Chemi-SiL: MB: 90 s; HB: (No explicit value given, implied to be comparable to "Fast"); LB: 90 s; LBS: (No explicit value given, implied to be comparable to "Fast") | Equivalent | |
| Setting reaction time | Vonflex STM: 4'00" (Heavy, normal); 2'30" (Heavy, Fast); 4'00" (Light, normal); 2'30" (Light, Fast) | Chemi-SiL: MB: 210 s; HB: (N/A, implied to be comparable to "Fast"); LB: 210 s; LBS: (N/A, implied to be comparable to "Fast") | Equivalent |
| Consistency | Vonflex STM: 34.76 mm (Heavy, normal); 34.78 mm (Heavy, Fast); 43.43 mm (Light, normal); 42.02 mm (Light, Fast) | ||
| [ISO 4823:2021 7.2] = 36 mm (Light) | Chemi-SiL: MB: 32.75 mm; HB: (N/A); LB: 48.83 mm; LBS: (N/A) | Equivalent. All values meet the ISO criteria. | |
| Compatibility with gypsum | Vonflex STM: Reproduced for 0.05 mm | ||
| [ISO 4823:2021 7.6] 50 µm should be reproduced without interruption. | Chemi-SiL: Reproduced for 0.05 mm | Equivalent. Both conform to the standard. | |
| Strain in compression | Vonflex STM: 2.56 % (Heavy, normal); 2.38 % (Heavy, Fast); 7.71 % (Light, normal); 5.24 % (Light, Fast) | ||
| [ISO 4823:2021 7.8] 0.8 | Chemi-SiL: MB: 1.2 %; HB: (N/A); LB: 3.1 %; LBS: (N/A) | Similar. Both conform to the standard. Chemi-SiL values fall within or are superior to the predicate and standard ranges. | |
| Linear Dimensional Change | Vonflex STM: 0.11 % (Heavy, normal); 0.07 % (Heavy, Fast); 0.08 % (Light, normal); 0.09 % (Light, Fast) | ||
| [ISO 4823:2021 7.5] |
§ 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).