The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Intermezzo Plus Fixture.
| Device ID | K053354 |
| 510k Number | K053354 |
| Device Name: | INTERMEZZO PLUS FIXTURE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Dae Chang |
| Correspondent | Dae Chang MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa 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 | 2005-12-02 |
| Decision Date | 2006-04-13 |
| Summary: | summary |