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 |
|---|---|---|---|
| K251188 | uniqa dental | UNIQA® Dental Implants System | June 25, 2026 |
| K251232 | megagen implant co | MegaGen Zygoma Dental Implant System | June 18, 2026 |
| K250806 | a.b. dental devices | Dental Implant System | June 18, 2026 |
| K260006 | inosys | INOSS System | June 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 | March 23, 2026 |
| K253334 | izenimplant co | ZENEX Implant System_Short (R-System) | March 16, 2026 |
| K252168 | institut straumann | Straumann® BLC Implants - Indication Widening | March 10, 2026 |
| K253493 | dentis co | Dentis SQ-SL AXEL Fixture | March 4, 2026 |
| K252197 | nobel biocare | Nobel Biocare S Series Implants | February 18, 2026 |
| K252286 | chengdu besmile medical technology co | BIORES Dental Implant System | February 2, 2026 |
| K252585 | izenimplant co | ZENEX Implant System_R-System | January 8, 2026 |
| K250476 | paragon implant mfg | NizPlant Dental Implant System | December 23, 2025 |
| K252145 | paragon implant mfg | GEN5 and GEN5+ 3.3mmD Dental Implants | December 23, 2025 |
| K251605 | dimplo | DIMPLO Implant System | December 22, 2025 |
| K252090 | jjgc indústria e comércio de materiais dentários | Pterygoid Indication for GM Helix Implants | December 12, 2025 |
| K251129 | s.i.n. implant system ltda | S.I.N. Tapered Pro Conical Zygoma Implant System | November 7, 2025 |
| K251938 | paragon implant mfg | GEN5 and GEN5+ Dental Implant System | October 30, 2025 |
| K243078 | osseofuse international | HexaPLUS S OneDrill Implant System | October 10, 2025 |
| K243983 | paltop advanced dental solutions | Paltop Dental Implant System | September 29, 2025 |