The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Exfeel Implant System.
| Device ID | K052369 |
| 510k Number | K052369 |
| Device Name: | EXFEEL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu 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 | 2005-08-29 |
| Decision Date | 2006-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809728991605 | K052369 | 000 |
| 08809708751427 | K052369 | 000 |
| 08806388222957 | K052369 | 000 |
| 08806388222940 | K052369 | 000 |
| 08806388222889 | K052369 | 000 |
| 08806388222841 | K052369 | 000 |
| 08806388222803 | K052369 | 000 |
| 08806388222766 | K052369 | 000 |
| 08806388222728 | K052369 | 000 |
| 08806388222681 | K052369 | 000 |
| 08806388222643 | K052369 | 000 |
| 08806388222605 | K052369 | 000 |
| 08806388222575 | K052369 | 000 |
| 08809728991469 | K052369 | 000 |
| 08809728991476 | K052369 | 000 |
| 08809728991599 | K052369 | 000 |
| 08809728991582 | K052369 | 000 |
| 08809728991575 | K052369 | 000 |
| 08809728991568 | K052369 | 000 |
| 08809728991551 | K052369 | 000 |
| 08809728991544 | K052369 | 000 |
| 08809728991537 | K052369 | 000 |
| 08809728991520 | K052369 | 000 |
| 08809728991513 | K052369 | 000 |
| 08809728991506 | K052369 | 000 |
| 08809728991490 | K052369 | 000 |
| 08809728991483 | K052369 | 000 |
| 08806388222568 | K052369 | 000 |