DZE — Implant, Endosseous, Root-Form Class II
FDA product code DZE covers "Implant, Endosseous, Root-Form", a Class II medical device regulated under 21 CFR 872.3640. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DZE
- Device Class
- Class II
- Regulation Number
- 872.3640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261392 | Paragon Implant Mfg | TriActive Dental Implant System | Sep 17, 2026 |
| K260463 | Zeros Co | ZEROS Dental Implant System | Aug 19, 2026 |
| K251188 | Uniqa Dental | UNIQA® Dental Implants System | Jun 25, 2026 |
| K251232 | Megagen Implant Co | MegaGen Zygoma Dental Implant System | Jun 18, 2026 |
| K250806 | A.B. Dental Devices | Dental Implant System | Jun 18, 2026 |
| K260006 | Inosys | INOSS System | Jun 17, 2026 |
| K252731 | Promimic | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implan | May 12, 2026 |
| K252031 | Adin Dental Implant Systems | Adin Long Dental Implant System | Mar 23, 2026 |
| K253334 | Izenimplant Co | ZENEX Implant System_Short (R-System) | Mar 16, 2026 |
| K252168 | Institut Straumann | Straumann® BLC Implants - Indication Widening | Mar 10, 2026 |
| K253493 | Dentis Co | Dentis SQ-SL AXEL Fixture | Mar 4, 2026 |
| K252197 | Nobel Biocare | Nobel Biocare S Series Implants | Feb 18, 2026 |
| K252286 | Chengdu Besmile Medical Technology Co | BIORES Dental Implant System | Feb 2, 2026 |
| K252585 | Izenimplant Co | ZENEX Implant System_R-System | Jan 8, 2026 |
| K250476 | Paragon Implant Mfg | NizPlant Dental Implant System | Dec 23, 2025 |
| K252145 | Paragon Implant Mfg | GEN5 and GEN5+ 3.3mmD Dental Implants | Dec 23, 2025 |
| K251605 | Dimplo | DIMPLO Implant System | Dec 22, 2025 |
| K252090 | Jjgc Indústria E Comércio De Materiais Dentários | Pterygoid Indication for GM Helix Implants | Dec 12, 2025 |
| K251129 | S.I.N. Implant System Ltda | S.I.N. Tapered Pro Conical Zygoma Implant System | Nov 7, 2025 |
| K251938 | Paragon Implant Mfg | GEN5 and GEN5+ Dental Implant System | Oct 30, 2025 |