Sterilization Trays— 510(k) K251756

Substantially Equivalent

Paragon Implant Mfg., LLC

FDA 510(k) clearance K251756 for Sterilization Trays, Substantially Equivalent on 2025-11-14. Applicant: Paragon Implant Mfg., LLC. Device class: 2.

Clearance details

Applicant: Paragon Implant Mfg., LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2025-06-09
Decision date: 2025-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calabasas, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

More clearances from Paragon Implant Mfg., LLC

K250476 — NizPlant Dental Implant System2025-12-23
K252145 — GEN5 and GEN5+ 3.3mmD Dental Implants2025-12-23
K251938 — GEN5 and GEN5+ Dental Implant System2025-10-30

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