DZE — Implant, Endosseous, Root-Form Class II
FDA Device Classification
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 |
|---|
| 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 |
| K251262 | s.i.n. implant system ltda | S.I.N. Dental Implant System | September 26, 2025 |
| K251148 | jdentalcare | JDEvolution Plus L and JDEvolution Plus LE | September 25, 2025 |
| K243834 | nobel biocare | NobelZygoma TiUltra Implant system | August 25, 2025 |
| K251647 | dentsply sirona | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lanc | August 21, 2025 |
| K250271 | jjgc indústria e comércio de materiais dentários | Neodent Implant System - Zirconia Implant System | August 18, 2025 |
| K251046 | s.i.n. implant system ltda | S.I.N. Dental Implant System | August 13, 2025 |
| K250294 | institut straumann | Straumann® RidgeFit Implants | August 12, 2025 |