Nobel Biocare S Series Implants
FDA 510(k) K252197 · Nobel Biocare AB
510(k) numberK252197
Submission
- Device name
- Nobel Biocare S Series Implants
- Applicant
- Nobel Biocare AB
Goteborg, SE - Received
- July 14, 2025
- Decision date
- February 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| 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 |
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| K243834 | NobelZygoma TiUltra Implant systemDZE · Traditional | 08/25/2025SE |
| K240346 | NobelProcera Zirconia Implant BridgeNHA · Traditional | 01/03/2025SE |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNHA · Traditional | 01/24/2024SE |
| K231898 | DTX Studio Clinic (4.0)LLZ · Traditional | 12/08/2023SE |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCCNHA · Traditional | 04/28/2023SE |
| K221921 | DTX Studio Clinic 3.0MYN · Traditional | 03/28/2023SE |
| K213562 | DTX Studio Clinic 3.0LLZ · Traditional | 03/25/2022SE |
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Questions and answers
When was Nobel Biocare S Series Implants cleared by the FDA?
Nobel Biocare S Series Implants (K252197) received a 510(k) decision of Substantially Equivalent on February 18, 2026, 219 days after the submission was received.
What is the product code of K252197?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.