# K143117: Wire Sterilization Package with Indicators

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Oct 29, 2015 after 364 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990567 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators, Safe Secure Packaging Co., Ltd. (2012) Summary page 4.
- K951113: Cross-Checks, Steritec Products Mfg Co, Inc. (1996) Summary page 5.

## Indications for use
Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics’ line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to signify exposure to steam or ethylene oxide gas and distinguish between processed and unprocessed wire. STERILIZATION PARAMETERS Ethylene Oxide [100% E.O.] Gas 1. EO Concentration: 725 mg/L 2. Exposure Temperature: 130°F (55°C) 3. Exposure Time: 1 hour 4. Aeration Time: 8 hours Upon completion of the process, the EO color indicator will change from Blue to Cocoa Brown. Steam – Gravity 1. Exposure Temperature: 270°F (132°C) 2. Exposure Time: 15 minutes 3. Dry Time: 30 minutes Upon completion of the process, the STEAM color indicator will change from Blue to Black/Brownish Black. Please Note: Upon completion of the process, the archwire is to be used immediately.

Source page: https://510kreport.com/device/K143117
Methodology: https://510kreport.com/methodology