Product code DZE: 510(k) clearances and predicates
Product code DZE covers TriActive Dental Implant System. FDA lists 1549 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
1549 clearances on file under product code DZE. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 34 |
| 2023 | 35 |
| 2024 | 40 |
| 2025 | 31 |
| 2026 so far | 14 |
Recent clearances
Newest DZE clearances in the FDA index, with applicant and decision date:
- K261392, TriActive Dental Implant System, applicant Paragon Implant Mfg., LLC, decided 2026-09-17. FDA record
- K260463, ZEROS Dental Implant System, applicant Zeros Co., Ltd., decided 2026-08-19. FDA record
- K251188, UNIQA® Dental Implants System, applicant Uniqa Dental, Ltd., decided 2026-06-25. FDA record
- K250806, Dental Implant System, applicant A.B. Dental Devices , Ltd., decided 2026-06-18. FDA record
- K251232, MegaGen Zygoma Dental Implant System, applicant Megagen Implant Co., Ltd., decided 2026-06-18. FDA record
- K260006, INOSS System, applicant Inosys, Inc., decided 2026-06-17. FDA record
- K252731, Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant, applicant Promimic AB, decided 2026-05-12. FDA record
- K252031, Adin Long Dental Implant System, applicant Adin Dental Implant Systems , Ltd., decided 2026-03-23. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include ZEROS Dental Implant System, UNIQA® Dental Implants System. Watch new DZE clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DZE?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DZE clearances include TriActive Dental Implant System.
How many 510(k) clearances use product code DZE?
1549 at the time this page was generated, from openFDA records.
How do I find a predicate device under DZE?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DZE clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.