The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Dentria Series.
| Device ID | K160140 |
| 510k Number | K160140 |
| Device Name: | DENTRIa Series |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | HDX WILL CORP. #105, 201, 202, 203, 204, 38 OSONGSAENGMYEONG 4-RO, OSONG-EUP HEUNGDEOK-GU Cheongju-si, KR 28161 |
| Contact | Hyung-suk Oh |
| Correspondent | Hyung-suk Oh HDX WILL CORP. #105, 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 | 2016-01-21 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200045 | K160140 | 000 |
| 08800005200038 | K160140 | 000 |
| 08800005200021 | K160140 | 000 |