Straumann Dental Implant System
FDA 510(k) K033984 · Institut Straumann AG
510(k) numberK033984
Submission
- Device name
- Straumann Dental Implant System
- Applicant
- Institut Straumann AG
Waltham, MA, US - Received
- December 23, 2003
- Decision date
- June 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | 06/03/2026SE |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional | 05/07/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | 03/10/2026SE |
| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
Questions and answers
When was Straumann Dental Implant System cleared by the FDA?
Straumann Dental Implant System (K033984) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 190 days after the submission was received.
What is the product code of K033984?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.