Re-Bag Multi-Use Pouch, Large & Small

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954185 ↗

FDA Product Code

KCT

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Miltex Rigid Sterilization Container System, (47 Components)

  Class II

  FDA 510(k) K061033 Active Cleared 12 Dec 2006

• Miltex Membrane Tack Kit

  Class II

  FDA 510(k) K092855 Active Cleared 29 Dec 2009

• Dental Instruments - Cutting Instrument

  Class I

  FDA 510(k) K823326 Active Cleared 24 Nov 1982

• Dental Instruments - Files

  Class I

  FDA 510(k) K823316 Active Cleared 24 Nov 1982

• Dental Instruments - Probes

  Class I

  FDA 510(k) K823324 Active Cleared 24 Nov 1982

• Dental Instruments - Excavators

  Class I

  FDA 510(k) K823318 Active Cleared 24 Nov 1982

See all devices from Miltex, Inc. →