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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800142100598 | K222414 | 000 |
| 08800142100574 | K222414 | 000 |
| 08800142100550 | K222414 | 000 |
| 08800142100536 | K222414 | 000 |
| 08800142100512 | K222414 | 000 |
| 08800142100499 | K222414 | 000 |