510(k) K251756

Sterilization Trays by Paragon Implant Mfg., LLC — Product Code KCT

K251756 is an FDA 510(k) premarket notification submitted by Paragon Implant Mfg., LLC for the device "Sterilization Trays". The FDA issued a decision of Substantially Equivalent on November 14, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Paragon Implant Mfg., LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2025
Date Received
June 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type