OsteoCentric Dental Implant System
FDA 510(k) K230242 · OsteoCentric Technologies
510(k) numberK230242
Submission
- Device name
- OsteoCentric Dental Implant System
- Applicant
- OsteoCentric Technologies
Logan, UT, US - Received
- January 30, 2023
- Decision date
- October 5, 2023
- 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 |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments SystemOLO · Traditional | 10/27/2025SE |
| K251913 | OsteoCentric® UnifiMI® TCS Plating SystemHRS · Special | 08/16/2025SE |
| K250494 | The OsteoCentric Bone Plate and Screw SystemHRS · Special | 03/18/2025SE |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and NutsHWC · Special | 10/09/2024SE |
| K230226 | Integrity-SI® Fusion SystemOUR · Special | 09/21/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | 06/29/2023SE |
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | 04/18/2023SE |
| K222512 | Integrity-SI Fusion SystemOUR · Special | 09/12/2022SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | 07/28/2022SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | 08/03/2021SE |
Questions and answers
When was OsteoCentric Dental Implant System cleared by the FDA?
OsteoCentric Dental Implant System (K230242) received a 510(k) decision of Substantially Equivalent on October 5, 2023, 248 days after the submission was received.
What is the product code of K230242?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.