The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Premilled Titanium Block System.
| Device ID | K203344 |
| 510k Number | K203344 |
| Device Name: | Premilled Titanium Block 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2021-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039372916 | K203344 | 000 |
| 08800177354737 | K203344 | 000 |
| 08800177354744 | K203344 | 000 |
| 08800177354751 | K203344 | 000 |
| 08800177354768 | K203344 | 000 |
| 08800177354775 | K203344 | 000 |
| 08800177354782 | K203344 | 000 |
| 08800177354799 | K203344 | 000 |
| 08800177354805 | K203344 | 000 |
| 08800039373531 | K203344 | 000 |
| 08800039373517 | K203344 | 000 |
| 08800039373432 | K203344 | 000 |
| 08800039372114 | K203344 | 000 |
| 08800039372138 | K203344 | 000 |
| 08800039372190 | K203344 | 000 |
| 08800039372213 | K203344 | 000 |
| 08800039373319 | K203344 | 000 |
| 08800039373333 | K203344 | 000 |
| 08800039373395 | K203344 | 000 |
| 08800039373418 | K203344 | 000 |
| 08800177354812 | K203344 | 000 |
| 08800177354829 | K203344 | 000 |
| 08800177354836 | K203344 | 000 |
| 08800177354652 | K203344 | 000 |
| 08800177354669 | K203344 | 000 |
| 08800177354676 | K203344 | 000 |
| 08800177354683 | K203344 | 000 |
| 08800177354690 | K203344 | 000 |
| 08800177354706 | K203344 | 000 |
| 08800177354713 | K203344 | 000 |
| 08800177354720 | K203344 | 000 |
| 08800177354645 | K203344 | 000 |
| 08800177354638 | K203344 | 000 |
| 08800177354621 | K203344 | 000 |
| 08800177354843 | K203344 | 000 |
| 08800039372237 | K203344 | 000 |
| 08800039372312 | K203344 | 000 |
| 08800039372336 | K203344 | 000 |
| 08800039372411 | K203344 | 000 |
| 08800039372435 | K203344 | 000 |
| 08800039373296 | K203344 | 000 |
| 08800177354614 | K203344 | 000 |
| 08800039372091 | K203344 | 000 |