The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ccm Abutment System.
| Device ID | K173120 |
| 510k Number | K173120 |
| Device Name: | CCM Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Bo-reum Yoo |
| Correspondent | April Lee Withus Group Inc 2531 Pepperdale Drive Rowland Heights, CA 91748 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039379243 | K173120 | 000 |
| 08800039364522 | K173120 | 000 |
| 08800090660939 | K173120 | 000 |
| 08800090660946 | K173120 | 000 |
| 08800090660953 | K173120 | 000 |
| 08800090660960 | K173120 | 000 |
| 08800039303170 | K173120 | 000 |
| 08800039303187 | K173120 | 000 |
| 08800039364553 | K173120 | 000 |
| 08800039364560 | K173120 | 000 |
| 08800039364577 | K173120 | 000 |
| 08800039364607 | K173120 | 000 |
| 08800039364621 | K173120 | 000 |
| 08800039379236 | K173120 | 000 |
| 08800039379618 | K173120 | 000 |