The following data is part of a premarket notification filed by Megagen Implant Co., Ltd with the FDA for Xpeed Any Ridge Internal Implant System.
| Device ID | K122231 |
| 510k Number | K122231 |
| Device Name: | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. 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 | 2012-07-26 |
| Decision Date | 2012-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806388202713 | K122231 | 000 |
| 08809708759966 | K122231 | 000 |
| 08809708759973 | K122231 | 000 |
| 08809708759980 | K122231 | 000 |
| 08806388202058 | K122231 | 000 |
| 08806388202065 | K122231 | 000 |
| 08806388202072 | K122231 | 000 |
| 08806388202089 | K122231 | 000 |
| 08806388202416 | K122231 | 000 |
| 08806388202454 | K122231 | 000 |
| 08806388202591 | K122231 | 000 |
| 08806388202638 | K122231 | 000 |
| 08806388202645 | K122231 | 000 |
| 08806388202669 | K122231 | 000 |
| 08806388202676 | K122231 | 000 |
| 08806388202683 | K122231 | 000 |
| 08806388202706 | K122231 | 000 |
| 08806388297252 | K122231 | 000 |