The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dionavi-denture02.
| Device ID | K210828 |
| 510k Number | K210828 |
| Device Name: | DIOnavi-Denture02 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DIO Corporation 66, Centumseo-ro, Haeundae-gu, Busan, KR 48058 |
| Contact | Ji-ae Park |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2021-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806169099501 | K210828 | 000 |
| 08800049401842 | K210828 | 000 |
| 08800049400906 | K210828 | 000 |
| 08800049400890 | K210828 | 000 |