The following data is part of a premarket notification filed by Seilglobal Co., Ltd. with the FDA for Dentiann Smart Sil.
| Device ID | K143382 |
| 510k Number | K143382 |
| Device Name: | DentiAnn Smart Sil |
| Classification | Material, Impression |
| Applicant | SeilGlobal Co., Ltd. 191, Gaejwa-ro, Geumjeong-gu Busan, KR 609-845 |
| Contact | Pack Seong Uk |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2015-02-23 |
| Summary: | summary |