The following data is part of a premarket notification filed by Graphy Inc. with the FDA for Tera Harz Denture.
Device ID | K222414 |
510k Number | K222414 |
Device Name: | TERA HARZ DENTURE |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-ro, Geumcheon-gu, Seoul, KR 08503 |
Contact | Tae-woo Kim |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2022-08-10 |
Decision Date | 2022-08-11 |