The following data is part of a premarket notification filed by Dio Corporation with the FDA for Uf(ii) Bar Holder Abutment.
| Device ID | K193404 |
| 510k Number | K193404 |
| Device Name: | UF(II) Bar Holder Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DIO Corporation 66, Centumseo-ro, Haeundae-gu, Busan, KR 48058 |
| Contact | Jiae Park |
| Correspondent | Joyce Kwon Provision Consulting Group Inc. 100 N. Barranca Street, Suite 700 West Covina, CA 91791 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806169098894 | K193404 | 000 |
| 08806169097286 | K193404 | 000 |
| 08806169097293 | K193404 | 000 |
| 08806169097309 | K193404 | 000 |
| 08806169097316 | K193404 | 000 |
| 08806169097323 | K193404 | 000 |
| 08806169097330 | K193404 | 000 |
| 08806169097347 | K193404 | 000 |
| 08806169098825 | K193404 | 000 |
| 08806169098832 | K193404 | 000 |
| 08806169098849 | K193404 | 000 |
| 08806169098856 | K193404 | 000 |
| 08806169098863 | K193404 | 000 |
| 08806169098870 | K193404 | 000 |
| 08806169098887 | K193404 | 000 |
| 08806169097279 | K193404 | 000 |