The following data is part of a premarket notification filed by We Dong Myung Dental Industrial Co., Ltd. with the FDA for E-sarang 86, Dm78, Dm55.
| Device ID | K033435 |
| 510k Number | K033435 |
| Device Name: | E-SARANG 86, DM78, DM55 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. 1733 CANTON LN. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-28 |
| Decision Date | 2003-11-12 |
| Summary: | summary |