DentiAnn Smart Sil Impression Material
by Seilglobal Co., Ltd. South Korea EUDAMED510(k)
510(k) K143382
Product code ELW
Overview
The DentiAnn Smart Sil Impression Material is a dental impression material designed for capturing precise oral impressions. Classified as a material for dental impressions, it is intended for use in creating accurate molds of teeth and surrounding structures, facilitating the fabrication of dental prosthetics, orthodontic appliances, or diagnostic models.
This material is supplied in multiple reference codes (e.g., 4565, 3003762341) and is regulated under FDA 510(k) clearance (K143382) and the EU Medical Device Regulation (MDR). It is intended for single-use applications in dental settings, with no indication of MRI compatibility or reusable design. Storage and handling should adhere to manufacturer guidelines to maintain sterility and performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK143382 | Date23 Feb 2015 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- DentiAnn Smart Sil
- 510(k) Number
- FDA Product Code
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Seilglobal Co., Ltd.
Questions
What is the DentiAnn Smart Sil Impression Material primarily used for in dental procedures?
The DentiAnn Smart Sil Impression Material is specifically designed for capturing precise oral impressions of teeth and surrounding structures. This allows dental professionals to create accurate molds that facilitate the fabrication of dental prosthetics, orthodontic appliances, or diagnostic models, ensuring a tailored fit for patient-specific needs.
Is the DentiAnn Smart Sil Impression Material intended for single-use or reusable applications?
The DentiAnn Smart Sil Impression Material is explicitly intended for single-use applications in dental settings. This design ensures patient safety and sterility, as reuse is not supported or recommended by the manufacturer.
How should the DentiAnn Smart Sil Impression Material be stored to maintain its performance?
The manufacturer recommends adhering to specific storage and handling guidelines to preserve sterility and performance. While exact conditions aren’t detailed in the data, typical dental impression materials require protection from moisture, extreme temperatures, and contamination. Always follow the manufacturer’s instructions included with the product to ensure optimal results.
What regulatory pathways has the DentiAnn Smart Sil Impression Material followed for approval?
The DentiAnn Smart Sil Impression Material has undergone regulatory review through FDA 510(k) clearance (K143382) and compliance with the EU Medical Device Regulation (MDR). The FDA submission was classified under device class 2 and filed under product code ELW, with a decision of *Substantially Equivalent* (SESE) by the Dental (DE) Advisory Committee. This confirms its compliance with dental impression material standards.
Are there multiple reference codes or variants available for the DentiAnn Smart Sil Impression Material?
Yes, the DentiAnn Smart Sil Impression Material is supplied across multiple reference codes, including (but not limited to) 4565, 3003762341, 3013020540, and others listed in the data. These codes likely correspond to different packaging sizes, formulations, or regional variants. Always verify the specific code matches your intended use before ordering.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K143382
- EUDAMED