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 |