The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dionavi-denture.
| Device ID | K193623 |
| 510k Number | K193623 |
| Device Name: | DIOnavi-Denture |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DIO Corporation 66, Centum Seo-ro, Haeundae-gu Busan, KR 48058 |
| Contact | Jiae Park |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806169098672 | K193623 | 000 |
| 08806169098665 | K193623 | 000 |
| 08806169098658 | K193623 | 000 |