The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Ez Plus Implant System.
| Device ID | K070562 |
| 510k Number | K070562 |
| Device Name: | EZ PLUS IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Dae K Chang |
| Correspondent | Dae K Chang MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-27 |
| Decision Date | 2007-05-18 |
| Summary: | summary |