EM SA Implant System
FDA 510(k) K191201 · Hiossen, Inc.
510(k) numberK191201
Submission
- Device name
- EM SA Implant System
- Applicant
- Hiossen, Inc.
Fariless Hills, PA, US - Received
- May 6, 2019
- Decision date
- November 15, 2019
- 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 |
|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | 05/14/2026SE |
| K251427 | Ek Multi Angled 30 AbutmentNHA · Traditional | 01/29/2026SE |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA · Abbreviated | 01/08/2025SE |
| K240232 | EK D3.3 and Ultra Wide ImplantsDZE · Traditional | 09/13/2024SE |
| K233389 | EK Digital AbutmentsNHA · Traditional | 05/29/2024SE |
| K222636 | ET Abutment SystemNHA · Traditional | 04/28/2023SE |
| K203360 | EK Implants and Abutments SystemDZE · Traditional | 01/07/2022SE |
| K191751 | EM ProvisionalDZE · Abbreviated | 12/16/2019SE |
| K183242 | ET IV SA Dental ImplantsDZE · Special | 05/21/2019SE |
| K180527 | IS3EKX · Traditional | 05/16/2018SE |
Questions and answers
When was EM SA Implant System cleared by the FDA?
EM SA Implant System (K191201) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 193 days after the submission was received.
What is the product code of K191201?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.