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FDA 510(k)

Sterilization Trays

K-Number: K251756 · 2025-11-14

ApplicantParagon Implant Mfg., LLC
Decision Date2025-11-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Trays is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K251756. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilization Trays?

Sterilization Trays is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Paragon Implant Mfg., LLC. The 510(k) number is K251756.

When did Sterilization Trays receive FDA 510(k) clearance?

Sterilization Trays received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251756.

Who is the listed applicant for Sterilization Trays?

The FDA 510(k) record lists Paragon Implant Mfg., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Trays?

The FDA product code for Sterilization Trays is KCT.

Other records listing Paragon Implant Mfg., LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsK250476NizPlant Dental Implant SystemK251938GEN5 and GEN5+ Dental Implant System

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251300Plastic Surgical KitsDentsply Sirona, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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