The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Dentioiii Series (dentioiii, Dentioiii-s).
| Device ID | K181297 |
| 510k Number | K181297 |
| Device Name: | DENTIOIII Series (DENTIOIII, DENTIOIII-S) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Lee Myoung-joon |
| Correspondent | Lee Myoung-joon HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200120 | K181297 | 000 |
| 08800005200113 | K181297 | 000 |