The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs Implant System Ii.
| Device ID | K200753 |
| 510k Number | K200753 |
| Device Name: | IBS Implant System II |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Bo-yeon Lim |
| 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 | 2020-03-23 |
| Decision Date | 2020-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039321396 | K200753 | 000 |
| 08800039380164 | K200753 | 000 |
| 08800039380171 | K200753 | 000 |
| 08800039380195 | K200753 | 000 |
| 08800039380225 | K200753 | 000 |
| 08800039380232 | K200753 | 000 |
| 08800039380249 | K200753 | 000 |
| 08800039380461 | K200753 | 000 |
| 08800090662704 | K200753 | 000 |
| 08800039380133 | K200753 | 000 |
| 08800039380102 | K200753 | 000 |
| 08800039380072 | K200753 | 000 |
| 08800039321433 | K200753 | 000 |
| 08800039321440 | K200753 | 000 |
| 08800039321457 | K200753 | 000 |
| 08800039321471 | K200753 | 000 |
| 08800039321402 | K200753 | 000 |
| 08800039321419 | K200753 | 000 |
| 08800039321426 | K200753 | 000 |
| 08800039380041 | K200753 | 000 |
| 08800090662582 | K200753 | 000 |
| 08800090662599 | K200753 | 000 |
| 08800090662605 | K200753 | 000 |
| 08800039380096 | K200753 | 000 |
| 08800039380119 | K200753 | 000 |
| 08800039380126 | K200753 | 000 |
| 08800039380140 | K200753 | 000 |
| 08800039380157 | K200753 | 000 |
| 08800039380201 | K200753 | 000 |
| 08800039380218 | K200753 | 000 |
| 08800039380447 | K200753 | 000 |
| 08800039380089 | K200753 | 000 |
| 08800039380065 | K200753 | 000 |
| 08800039380058 | K200753 | 000 |
| 08800090662612 | K200753 | 000 |
| 08800090662629 | K200753 | 000 |
| 08800090662636 | K200753 | 000 |
| 08800090662643 | K200753 | 000 |
| 08800090662650 | K200753 | 000 |
| 08800090662667 | K200753 | 000 |
| 08800090662674 | K200753 | 000 |
| 08800090662681 | K200753 | 000 |
| 08800039380454 | K200753 | 000 |