Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k) K252731 · Promimic AB
510(k) numberK252731
Submission
- Device name
- Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
- Applicant
- Promimic AB
Mölndal, SE - Received
- August 28, 2025
- Decision date
- May 12, 2026
- 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 |
| 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 |
| K252197 | Nobel Biocare S Series ImplantsDZE · Traditional | Nobel Biocare AB | 02/18/2026SE |
More from Nobel Biocare AB
| 510(k) | Device | Decision |
|---|---|---|
| K101225 | Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…DZE · Traditional | 01/25/2011SE |
Questions and answers
When was Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant cleared by the FDA?
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant (K252731) received a 510(k) decision of Substantially Equivalent on May 12, 2026, 257 days after the submission was received.
What is the product code of K252731?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.