The following data is part of a premarket notification filed by Megagen Implant Co., Ltd. with the FDA for Advanced Intermezzo Implant System.
| Device ID | K191127 |
| 510k Number | K191127 |
| Device Name: | Advanced Intermezzo Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu, KR |
| Contact | Jiyoung Son |
| Correspondent | Jiyoung Son MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu, KR |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806388275229 | K191127 | 000 |
| 08806388274499 | K191127 | 000 |
| 08806388274482 | K191127 | 000 |
| 08806388274475 | K191127 | 000 |
| 08806388274468 | K191127 | 000 |
| 08806388274451 | K191127 | 000 |
| 08806388274444 | K191127 | 000 |
| 08806388274437 | K191127 | 000 |
| 08806388274420 | K191127 | 000 |
| 08806388274413 | K191127 | 000 |
| 08806388274406 | K191127 | 000 |
| 08806388274390 | K191127 | 000 |
| 08806388274383 | K191127 | 000 |
| 08806388274376 | K191127 | 000 |
| 08806388274505 | K191127 | 000 |
| 08806388274512 | K191127 | 000 |
| 08806388274659 | K191127 | 000 |
| 08806388274642 | K191127 | 000 |
| 08806388274635 | K191127 | 000 |
| 08806388274628 | K191127 | 000 |
| 08806388274611 | K191127 | 000 |
| 08806388274604 | K191127 | 000 |
| 08806388274581 | K191127 | 000 |
| 08806388274574 | K191127 | 000 |
| 08806388274567 | K191127 | 000 |
| 08806388274550 | K191127 | 000 |
| 08806388274543 | K191127 | 000 |
| 08806388274536 | K191127 | 000 |
| 08806388274529 | K191127 | 000 |
| 08806388274369 | K191127 | 000 |