Implant Direct Dental Implant Systems Portfolio - MR Conditional
FDA 510(k) K222211 · Implant Direct Sybron Manufacturing, LLC
510(k) numberK222211
Submission
- Device name
- Implant Direct Dental Implant Systems Portfolio - MR Conditional
- Applicant
- Implant Direct Sybron Manufacturing, LLC
Thousand Oaks, CA, US - Received
- July 25, 2022
- Decision date
- February 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K231087 | Guided Surgery KitDZI · Traditional | 08/16/2023SE |
| K223535 | SMARTbase Abutment SystemNHA · Traditional | 06/20/2023SE |
| K202524 | Standard Sterilizable TrayKCT · Traditional | 01/28/2021SE |
| K201553 | Simply Iconic ImplantsDZE · Traditional | 01/22/2021SE |
| K200858 | Mini Sterilizable TrayKCT · Traditional | 08/06/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | 06/30/2020SE |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…DZE · Traditional | 06/25/2020SE |
| K192218 | Custom Legacy and Custom InterActive Titanium AbutmentsNHA · Traditional | 05/08/2020SE |
| K191458 | Legacy SMARTBase AbutmentsNHA · Traditional | 10/10/2019SE |
| K181359 | InterActive SMARTBase AbutmentsNHA · Traditional | 08/15/2018SE |
Questions and answers
When was Implant Direct Dental Implant Systems Portfolio - MR Conditional cleared by the FDA?
Implant Direct Dental Implant Systems Portfolio - MR Conditional (K222211) received a 510(k) decision of Substantially Equivalent on February 2, 2023, 192 days after the submission was received.
What is the product code of K222211?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.