The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magic Ucla Abutment System.
| Device ID | K202418 |
| 510k Number | K202418 |
| Device Name: | Magic UCLA Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Sun-mi Park |
| Correspondent | April Lee Withus Group Inc. 106 Superior Irvine, CA 92620 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-24 |
| Decision Date | 2020-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800090661561 | K202418 | 000 |
| 08800090661400 | K202418 | 000 |
| 08800090661417 | K202418 | 000 |
| 08800090661424 | K202418 | 000 |
| 08800090661431 | K202418 | 000 |
| 08800090661448 | K202418 | 000 |
| 08800090661455 | K202418 | 000 |
| 08800090661462 | K202418 | 000 |
| 08800090661479 | K202418 | 000 |
| 08800090661486 | K202418 | 000 |
| 08800090661493 | K202418 | 000 |
| 08800090661509 | K202418 | 000 |
| 08800090661516 | K202418 | 000 |
| 08800090661523 | K202418 | 000 |
| 08800090661530 | K202418 | 000 |
| 08800090661547 | K202418 | 000 |
| 08800090661554 | K202418 | 000 |
| 08800090661394 | K202418 | 000 |