The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Denfil.
| Device ID | K042124 |
| 510k Number | K042124 |
| Device Name: | DENFIL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VERICOM CO., LTD. #606,5TH DONGYOUNG VENTURESTEL 199-32, ANYANG 7-DONG,MANAN-GU Anyang-si, Gyeonggi-do, KR 430-817 |
| Contact | Myung-hwan Oh |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-06 |
| Decision Date | 2004-08-13 |
| Summary: | summary |