Neodent Implant System - GM Zygomatic Implant System
FDA 510(k) K232099 · JJGC Indústria e Comércio de Materiais Dentários S.A.
510(k) numberK232099
Submission
- Device name
- Neodent Implant System - GM Zygomatic Implant System
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
Curitiba, BR - Received
- July 13, 2023
- Decision date
- October 31, 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 |
|---|---|---|
| K261147 | Neodent Implant System - NeoConvert FitNHA · Traditional | 07/01/2026SE |
| K253922 | Neodent Scannable Healing AbutmentNHA · Traditional | 06/15/2026SE |
| K252727 | Neodent InLab Validated WorkflowNHA · Traditional | 01/07/2026SE |
| K252090 | Pterygoid Indication for GM Helix ImplantsDZE · Traditional | 12/12/2025SE |
| K250271 | Neodent Implant System - Zirconia Implant SystemDZE · Traditional | 08/18/2025SE |
| K241492 | Guided Surgery Kit CasesKCT · Traditional | 08/23/2024SE |
| K233857 | Neodent Implant System Custom AbutmentsNHA · Traditional | 05/02/2024SE |
| K231803 | Neodent Implant System - Zirconia Implant SystemNHA · Traditional | 12/13/2023SE |
| K230804 | Complement Kit CasesKCT · Traditional | 07/07/2023SE |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit CasesKCT · Traditional | 04/13/2022SE |
Questions and answers
When was Neodent Implant System - GM Zygomatic Implant System cleared by the FDA?
Neodent Implant System - GM Zygomatic Implant System (K232099) received a 510(k) decision of Substantially Equivalent on October 31, 2023, 110 days after the submission was received.
What is the product code of K232099?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.