The following data is part of a premarket notification filed by Dio Corporation with the FDA for Uf(ii) Wide Fixture.
| Device ID | K173975 |
| 510k Number | K173975 |
| Device Name: | UF(II) Wide Fixture |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO Corporation 66, Centum Seo-ro Haeundae-gu Busan, KR 48058 |
| Contact | Jiae Park |
| Correspondent | Peter Kang DIO USA 3470 Wilshire Blvd, #620 Los Angeles, CA 90010 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-06-01 |
| Summary: | summary |