The following data is part of a premarket notification filed by Dio Corporation with the FDA for Ucla Ccm Abutment.
| Device ID | K192263 |
| 510k Number | K192263 |
| Device Name: | UCLA CCM Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DIO Corporation 66, Centum Seo-ro, Haeundae-gu Busan, KR 48058 |
| Contact | Jiae Park |
| Correspondent | Peter Kang DIO USA #620, 3470 Wilshire Blvd Los Angeles, CA 90010 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2020-02-21 |