The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dio Cad/cam Abutment.
| Device ID | K181037 |
| 510k Number | K181037 |
| Device Name: | DIO CAD/CAM Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DIO Corporation 66, Centum Seo-ro, Haeundae-gu Busan, KR 48058 |
| Contact | Jiae 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 | 2018-04-19 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800049278925 | K181037 | 000 |
| 08800049278918 | K181037 | 000 |
| 08800049278901 | K181037 | 000 |
| 08800049278895 | K181037 | 000 |
| 08800049278888 | K181037 | 000 |
| 08800049278871 | K181037 | 000 |