GEN5 and GEN5+ 3.3mmD Dental Implants— 510(k) K252145

Name: FDA 510(k) clearance K252145
Creator: U.S. Food and Drug Administration
Published: 2025-12-23

Substantially Equivalent

Paragon Implant Mfg., LLC

FDA 510(k) clearance K252145 for GEN5 and GEN5+ 3.3mmD Dental Implants, Substantially Equivalent on 2025-12-23. Applicant: Paragon Implant Mfg., LLC. Device class: 2.

Clearance details

Applicant: Paragon Implant Mfg., LLC
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2025-07-09
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calabasas, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Paragon Implant Mfg., LLC

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K250476 — NizPlant Dental Implant System2025-12-23
K251756 — Sterilization Trays2025-11-14
K251938 — GEN5 and GEN5+ Dental Implant System2025-10-30

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.