The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for I-sil.
| Device ID | K161774 |
| 510k Number | K161774 |
| Device Name: | I-Sil |
| Classification | Material, Impression |
| Applicant | SPIDENT Co., Ltd. 203 & 312, Korea Indsutrial Complex, 722 Gojan-Dong, Namdong-Gu Incheon, KR 21692 |
| Contact | J. M. Ahn |
| Correspondent | Mark Choi SPIDENT USA Inc. 2115 Linwood Ave, 5F, Fort Lee, NJ 07024 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-28 |
| Decision Date | 2016-09-30 |
| Summary: | summary |