The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for Escom 100.
| Device ID | K110428 |
| 510k Number | K110428 |
| Device Name: | ESCOM 100 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SPIDENT CO., LTD. KOREA INDUSTRIAL COMPLEX 722 KOJAN-DONG, NAMDONG-KU Incheon, KR 405-821 |
| Contact | Je Mo Ahn |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20190723160274 | K110428 | 000 |
| 20210205180023 | K110428 | 000 |
| 08809262955576 | K110428 | 000 |
| 20200523170066 | K110428 | 000 |
| 20191004160150 | K110428 | 000 |
| 08809262955217 | K110428 | 000 |
| 08809262955224 | K110428 | 000 |
| 08809262955231 | K110428 | 000 |
| 08809262955248 | K110428 | 000 |
| 08809262955279 | K110428 | 000 |
| 00210205180029 | K110428 | 000 |
| 08809262955323 | K110428 | 000 |
| 20200723170323 | K110428 | 000 |
| 00210205180012 | K110428 | 000 |