Prosthetic devices · 21 CFR 872 Subpart D
Denture Preformed (Partially Prefabricated Denture)
FDA device type “Denture Preformed (Partially Prefabricated Denture)”.
- Companies listing it
- 2319 makers
- Brands and models
- 31
- 510(k) clearances
- 40 in five years
- FDA name
- Denture Preformed (Partially Prefabricated Denture)
510(k) clearances per year, 1976–2026
Companies that list EKO
23 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Clemde SA DE CV | Mexico | Maker | Partial Flex | 2 | 2025 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| Merz Dental GmbH | Germany | Maker | Baltic Denture System · BD Creator · BD Creator plus · BD Key (Upper & Lower Key) · +5 | 8 | 2017 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | STELLAR Attachment · STELLAR DC Acrylic · STELLAR LC Acrylic | 2 | 1986 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | China | Maker | DENTURE PREFORMED (PARTIALLY PREFABRICATEDDENTURE | 1 | 2020 |
| Nanjing Chamlion Laser Technology Co., Ltd. | China | Maker | Malo Bridge | — | — |
| one day dental partner | South Korea | Maker | kage Denture preformed (partially prefabricated denture) | — | — |
| Aadi Med Private Limited | India | Maker | Re-Inforcement Mesh (Golden / Silver) | — | — |
| China Dental Outsourcing Inc | China | Maker | DENTURE PREFORMED (PARTIA · Valplast | — | — |
| Shenzhen Jiahong Dental Technology Co., Ltd | China | Maker | EKO | — | — |
| Foo Tian Dental Laboratory | China | Maker | Dental Removable Prosthesis like metal dentures&acrylic dentures&valplast denture | — | — |
| Sonrisa | United States | Maker | Easy Denture | — | — |
| Caribbean Custom Mold Inc | Dominican Republic | Maker | Sonrisa | — | — |
| Kelsey Dental LLC | United States | Maker | medical titanium materials | — | — |
| Integrity Dental Services LLC | United States | Maker | Denture Preformed (Partially Prefabricated Denture) | — | — |
| Xi'an SinoTitanium Metals Co.,Ltd | China | Maker | medical titanium materials | — | — |
| Mabel Dental Lab | United States | Maker | Now Denture | — | — |
| Guangzhou Jinguanqiao Industry Co., Ltd | China | Maker | — | — | — |
| CreoDent Prosthetics LTD | United States | Repacker / relabeler | Denture | 9 | 2022 |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Partial Pre-fab Denture | — | — |
| Premiere 1 Dental Laboratory, LLC | United States | Repacker / relabeler | Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture, | — | — |
| JSB Dental, Inc. | United States | Repacker / relabeler | D496503 | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Dec 1990 | K903672 | DENE BRIDGE | Dirotian Pty. , Ltd. |
| 1 May 1989 | K892255 | DENTAL ROOT ELEVATOR | Zinnanti Surgical Instruments, Inc. |
| 26 May 1978 | K780722 | ADVANCED DENTURE SYSTEM | Advanced Marketing Research Co. |
| 15 Oct 1976 | K760768 | FLEXIDENT DENTURE | Flexodent Corp. |
Official records: FDA product classification for EKO · 21 CFR 872.3600.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026