TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
FDA 510(k) clearance K253681 · decided 2025-11-21
Clearance details
- K-number
- K253681
- Device name
- TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
- Applicant
- Graphy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-21
- Decision date
- 2025-11-21
- Days to decision
- 0 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seoul, KR
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Graphy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NanoCeram Resin (K262681) | 3BFAB TEKNOLOJI A.S. | 2026-07-31 |
| Denture Base Resin V2 (K262300) | Formlabs Ohio, Inc. | 2026-07-08 |
| DENTCA Tru Flexible (K261474) | Dentca, Inc. | 2026-07-01 |
| DB 4000 High Impact Denture Base (K260569) | Carbon, Inc. | 2026-06-02 |
| Denture Base (K260376) | Shandong Huge Dental Material Corporation | 2026-05-06 |
| LuxCreo Flexible Partial Denture Resin (K253365) | LuxCreo, Inc. | 2025-11-25 |
| UltraPrint-Dental Denture UV (K253324) | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| Freeprint® denture flex (K252430) | Detax GmbH | 2025-10-30 |
| DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (K252035) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 |
| Flexible Partial Resin (K250302) | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| Partial Flex (K242897) | Clemde SA DE CV | 2025-06-03 |
| FP3D (K250489) | Keystone Industries | 2025-05-20 |
Recalls involving this device
No recalls on record reference this clearance.