The following data is part of a premarket notification filed by Arum Dentistry Co. Ltd with the FDA for Pre-milled Blank.
| Device ID | K193425 |
| 510k Number | K193425 |
| Device Name: | Pre-Milled Blank |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Arum Dentistry Co. Ltd 1 Building, 44, Techno 8-ro Yuseong-gu, Daejeon, KR 34028 |
| Contact | Hwang-heung Yeon |
| Correspondent | Chris Brown Aclivi, Llc 6455 Farley Road Pinckney, MI 48169 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-10 |
| Decision Date | 2020-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800055700120 | K193425 | 000 |
| 08800055700113 | K193425 | 000 |
| 08800055700052 | K193425 | 000 |
| 08800055700045 | K193425 | 000 |
| 08800055700038 | K193425 | 000 |
| 08800055700021 | K193425 | 000 |
| 08800055700014 | K193425 | 000 |
| 08800055700007 | K193425 | 000 |