The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Dentria Series (dentria, Dentri-ca, Dentri-sa).
| Device ID | K212254 |
| 510k Number | K212254 |
| Device Name: | DENTRIa Series (DENTRIa, DENTRI-Ca, DENTRI-Sa) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | HDX Will Corp. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Kaon Kim |
| Correspondent | Kaon Kim HDX Will Corp. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2021-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200403 | K212254 | 000 |
| 08800005200397 | K212254 | 000 |
| 08800005200380 | K212254 | 000 |
| 08800005200434 | K212254 | 000 |
| 08800005200427 | K212254 | 000 |
| 08800005200410 | K212254 | 000 |