The following data is part of a premarket notification filed by Megagen Implant Co., Ltd. with the FDA for Xpeed Anyridge Internal Implant System.
| Device ID | K123870 |
| 510k Number | K123870 |
| Device Name: | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN IMPLANT CO., LTD. 325 N PUENTE STREET UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee MEGAGEN IMPLANT CO., LTD. 325 N PUENTE STREET UNIT B Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-03-27 |
| Summary: | summary |