ACERO ES & ESL ESTHETIC CROWNS
Optional Pre-Use High-Level Disinfection / Cold Chemical Sterilization Guidance
Acero ES and ESL crowns are supplied NONSTERILE.
For routine intended use, crowns contact oral mucous membranes and are treated as semicritical devices. CDC guidance states that heat-sensitive semicritical dental items should, at a minimum, receive high-level disinfection (HLD). Accordingly, when permitted by hospital, OR, ASC, or facility policy, HLD is Acero's preferred pre-use processing approach for these resin-veneered, heat-sensitive crowns.
PREFERRED OPTION - HIGH-LEVEL DISINFECTION (HLD)
Product: Revital-Ox® RESERT® High Level Disinfectant (STERIS)
Active ingredient: 2.0% nominal hydrogen peroxide; ready to use / use undiluted
HLD exposure: Minimum 8 minutes at ≥20°C (68°F)
Use: Completely immerse the new, unused crown and follow the current STERIS IFU for solution testing, immersion, rinsing, drying, handling, reuse life, and disposal.
Use HLD only when the facility's written infection-control policy permits HLD for a heat-sensitive semicritical device. HLD is not sterilization and must not be represented as sterilization.
SECONDARY OPTION - WHEN THE FACILITY REQUIRES STERILIZATION
If facility policy specifically requires sterilization rather than HLD, use one of the following liquid chemical sterilization methods for heat-sensitive devices, subject to Acero material-compatibility validation:
| Product | Chemistry | Sterilization cycle |
|---|---|---|
| Sporox® II (Dentsply Sirona) | 7.5% hydrogen peroxide glutaraldehyde-free | 6 hours at 20°C (68°F) |
| MetriCide™ 28 (Metrex) | 2.5% glutaraldehyde activated solution | 10 hours at 25°C (77°F) |
For either sterilant: follow the current manufacturer's complete sterilization IFU, including activation, minimum effective concentration testing, temperature, complete immersion, full sterilization exposure time, required rinsing, drying, aseptic handling, reuse life, ventilation/PPE, and disposal. Do not substitute a shorter HLD cycle for the full sterilization cycle.
IMPORTANT
- Do not steam autoclave or chemiclave ES or ESL crowns. Repeated heat/moisture exposure may adversely affect a resin veneer.
- These instructions apply to pre-use processing of a new, unused crown only.
- Inspect the crown after processing. Do not use if veneer cracking, lifting, delamination, marked discoloration, deformation, corrosion, or other visible damage is present.
- Facility policy controls. If the facility requires a sterile device, HLD alone does not satisfy that requirement.
Regulatory note: CDC classifies items that contact mucous membranes as semicritical and states that heat-sensitive semicritical dental items should receive at least HLD. CDC does not endorse a specific germicide brand. Product names and cycle parameters above are based on current manufacturer/FDA-cleared labeling and must be reconciled with the current product IFU.
ACERO XT, 3S, NA, and Z1 CROWNS
Disinfection/Sterilization Instructions
Clinician is responsible for sterilization / disinfection. (Cold sterilization, autoclave or steam sterilization may be used according to the sterilant or sterilizer manufacturer's standard instructions.)
Contaminated crowns should undergo the following disinfection/sterilization procedures prior to being re-stocked in inventory.
- Thoroughly wash crown to remove any debris or other contaminants from the internal and external surfaces of the crown.
- Place the crown in an ultrasonic cleaner containing standard disinfectant solution for 10 minutes.
- For cold sterilization: soak crown in cold sterilizing solution (such as 2% gluteraldehyde) for 10 hrs.
- For Autoclave or steam sterilization: place crowns in a sterilization pouch and run at 270 degrees for 5 minutes and dry for 30 minute cycle.
- Return crown to inventory being careful to place in proper storage compartment.
