(353 days)
Impression of inlay, onlay crown, and bridge preparation
- Crown, bridge impression
- Inlay and onlay impression
- Functional impression
- Denture impression
- Study model impression
Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.
The document is a 510(k) Summary for the dental impression material "Bright Impress" by Genoss Co., Ltd. It compares the characteristics of Bright Impress to a predicate device, HySil Impression Materials, and presents performance and biocompatibility data.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables for both biocompatibility and performance for each variant of "Bright Impress" (Light, Medium, Heavy, Putty, Bite). I will consolidate and present a representative sample, focusing on the "Performance Data" which directly addresses how the device meets physical/mechanical acceptance criteria. The "Biocompatibility Data" also uses "Acceptance Criteria" and "P/F" (Pass/Fail) results.
Comprehensive Table of Acceptance Criteria and Reported Device Performance
| Category | Item | Acceptance Criteria | Reported Performance (Bright Impress - Light) | Reported Performance (Bright Impress - Medium) | Reported Performance (Bright Impress - Heavy) | Reported Performance (Bright Impress - Putty) | Reported Performance (Bright Impress - Bite) |
|---|---|---|---|---|---|---|---|
| Biocompatibility (All variants) | |||||||
| Cytotoxicity | None cytotoxicity | Pass | Pass | Pass | Pass | Pass | Pass |
| Sensitization | None sensitization | Pass | Pass | Pass | Pass | Pass | Pass |
| Irritation/ Intracutaneous Reactivity | None irritation/intracutaneous reactivity | Pass | Pass | Pass | Pass | Pass | Pass |
| Systemic Toxicity (acute) | None systemic toxicity | Pass | Pass | Pass | Not reported for Heavy | Pass | Pass |
| Oral Mucosa Irritation | None irritation (Heavy) | Pass | Not reported for Light/Medium/Putty/Bite | Not reported for Light/Medium/Putty/Bite | Pass | Not reported for Light/Medium/Putty/Bite | Not reported for Light/Medium/Putty/Bite |
| Performance | |||||||
| Visual | No substance material | Pass | Pass | Pass | Pass | Pass | Pass |
| Volume/Capacity | Size error of Standard Size |
§ 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).