Home / 510(k) Clearances / K251614

510(k) K251614

Stainless Steel Surgical Kits by Dentsply Sirona, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2026
Date Received
May 27, 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

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Other clearances for product code KCT

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  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)
  • K242023 — Microdent Sterilization Cassette (February 19, 2025)