Home / 510(k) Clearances / K223756

510(k) K223756

SimPro™ Now, GentleCath™ Hydrophilic by Dentsply Sirona — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
December 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Dentsply Sirona

  • K253565 — SureSmile Software (March 4, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K252343 — Atlantis® Abutments in Titanium (December 9, 2025)
  • K252248 — CEREC Tessera Abutment System (November 26, 2025)
  • K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (November 21, 2025)
  • K250771 — Primescan 2 (August 29, 2025)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lanc (August 21, 2025)

Other clearances for product code EZD

  • K260502 — Liv Pre-lubricated Intermittent Catheter (March 12, 2026)
  • K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophil (January 29, 2026)
  • K251178 — Ready to use Nelaton Catheter (January 2, 2026)
  • K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (n (October 3, 2025)
  • K250659 — LoFric Origo (September 26, 2025)
  • K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twi (July 1, 2025)
  • K251116 — Luja Coudé (June 27, 2025)
  • K243175 — Disposable Intermittent Catheter (TPU Catheter) (June 26, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)