Tera Harz Denture
FDA 510(k) K222414 · Graphy, Inc.
510(k) numberK222414
Submission
- Device name
- Tera Harz Denture
- Applicant
- Graphy, Inc.
Seoul, KR - Received
- August 10, 2022
- Decision date
- August 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code EBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
| K261474 | DENTCA Tru FlexibleEBI · Traditional | Dentca, Inc. | 07/01/2026SE |
| K260569 | DB 4000 High Impact Denture BaseEBI · Abbreviated | Carbon, Inc. | 06/02/2026SE |
| K260376 | Denture BaseEBI · Traditional | Shandong Huge Dental Material Corporation | 05/06/2026SE |
| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
More from Guangzhou Heygears IMC., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | 11/21/2025SE |
| K240597 | Tera Harz ClearNXC · Special | 03/05/2024SE |
| K233502 | Tera Harz IIEBF · Traditional | 11/01/2023SE |
| K223355 | Tera Harz ClearNXC · Traditional | 11/03/2022SE |
| K202846 | Tera HarzEBF · Traditional | 07/15/2021SE |
Questions and answers
When was Tera Harz Denture cleared by the FDA?
Tera Harz Denture (K222414) received a 510(k) decision of Substantially Equivalent on August 11, 2022, 1 days after the submission was received.
What is the product code of K222414?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.