The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Well-paste.
| Device ID | K090992 |
| 510k Number | K090992 |
| Device Name: | WELL-PASTE |
| Classification | Resin, Root Canal Filling |
| Applicant | VERICOM CO., LTD. 2670 WALNUT AVE. SUITE N Tustin, CA 92780 |
| Contact | Jay Hwang |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-04-21 |
| Summary: | summary |