The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Well-pex.
| Device ID | K080266 |
| 510k Number | K080266 |
| Device Name: | WELL-PEX |
| Classification | Resin, Root Canal Filling |
| 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 | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-02-06 |
| Summary: | summary |