The following data is part of a premarket notification filed by Graphy Inc. with the FDA for Tera Harz.
| Device ID | K202846 |
| 510k Number | K202846 |
| Device Name: | TERA HARZ |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Graphy Inc. 1607, Gasan SK V1 Center, 171, Gasan Digital 1-ro, Geumcheon-gu, Seoul, KR 08503 |
| Contact | Tae-woo Kim |
| Correspondent | Peter Chung Plus Global 300 Atwood Street Pittsburgh, PA 15213 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800142100123 | K202846 | 000 |
| 08800142100116 | K202846 | 000 |
| 08800142100109 | K202846 | 000 |