Dental Implant System
FDA 510(k) K122807 · Hager& Meisinger GmbH
510(k) numberK122807
Submission
- Device name
- Dental Implant System
- Applicant
- Hager& Meisinger GmbH
Centennial, CO, US - Received
- August 30, 2012
- Decision date
- June 13, 2014
- 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 |
|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | 09/29/2025SE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | 10/17/2024SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | 10/08/2021SE |
| K173819 | MyPlant II Implant SystemDZE · Traditional | 08/09/2018SE |
| K180360 | OKTAGON Implant SystemDZE · Traditional | 05/10/2018SE |
| K170287 | Dental Implants OKTAGON Bone Level Tapered DesignDZE · Traditional | 05/24/2017SE |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone LevelDZE · Traditional | 02/24/2017SE |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…NHA · Traditional | 11/21/2016SE |
| K143539 | Dental Implant OKTAGON Bone LevelDZE · Traditional | 08/31/2015SE |
| K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…NHA · Traditional | 07/07/2014SE |
Questions and answers
When was Dental Implant System cleared by the FDA?
Dental Implant System (K122807) received a 510(k) decision of Substantially Equivalent on June 13, 2014, 652 days after the submission was received.
What is the product code of K122807?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.