The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Neoplant Implant System.
| Device ID | K042339 |
| 510k Number | K042339 |
| Device Name: | NEOPLANT IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEOBIOTECH CO., LTD. 13340E FIRESTONE BLVD. STE. J Sante Fe Springs, CA 90670 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu Chang NEOBIOTECH CO., LTD. 13340E FIRESTONE BLVD. STE. J Sante Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-11-02 |
| Summary: | summary |