The following data is part of a premarket notification filed by Graphy Inc. with the FDA for Tera Harz Clear.
| Device ID | K223355 |
| 510k Number | K223355 |
| Device Name: | Tera Harz Clear |
| Classification | Aligner, Sequential |
| Applicant | Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-ro, Geumcheon-gu, Seoul, KR 08503 |
| Contact | Moon Soo Part |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-11-02 |
| Decision Date | 2022-11-03 |