The following data is part of a premarket notification filed by We Dong Myung Dental Industrial Co., Ltd. with the FDA for Bestaloy.
| Device ID | K033434 |
| 510k Number | K033434 |
| Device Name: | BESTALOY |
| Classification | Alloy, Amalgam |
| 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. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| 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 |