Instructions For Use (IFU)

Intended Use

Used to guide compatible surgical instruments during osteotomy preparation according to the doctor’s approved treatment plan.

Storage

Store in a dry, clean area.
Avoid direct sunlight and heat exposure.

Cleaning and Disinfection

Delivered non-sterile.
Do not use heat or autoclave sterilization.
Clean and disinfect the surgical guide and compatible instrumentation prior to surgery.
Prior to using the surgical guide, rinse with water and place in chlorhexidine gluconate or an oral antiseptic (e.g., Listerine®) for 2–5 minutes, then rinse.

Materials

Surgical Guide: Stratasys MED610® (biocompatible resin)
Sleeves: Stainless Steel, PEEK, and/or Metal Alloy

Patient Fit

Single-use, patient-specific device.
Fit is based on diagnostic cast and CBCT scan data*.
Verify accurate seating on the patient’s dentition.
Minor adjustments may be made for proper seating.
Do not use if fit issues persist.

* Poor diagnostic data quality and improper guide seating may cause the drill position, trajectory, and/or depth to be off.

Position, Trajectory, and Depth

Inspect for damage or loose sleeves prior to use.
Verify drilling position, trajectory, and depth per plan documentation.
Do not proceed if there are discrepancies between the guide and the treatment plan.

Surgical Drilling

Confirm instrument compatibility with guide sleeves.
Start drill rotation after engagement with the sleeve.
Maintain constant irrigation to prevent bone overheating.
Use a gentle pumping motion for improved cooling and chip removal.
Avoid excessive force that may crack or deform the guide.
Frequently verify drilled depth with a depth probe.

Drill Tip Length

Tip length may not be included in the system’s total drill length. Understand your system depth calibration before drilling.

Warnings & Precautions

Delivered non-sterile.
Do not use heat or autoclave sterilization.
Do not use if the guide shows visible damage or instability.
Do not use if the guide does not fit.
Do not reuse after use.
Review all accompanying documentation before use.

Disposal

Dispose of the used guide in accordance with local biomedical waste regulations.

Device Validity

Valid only while the patient’s intraoral morphology matches the anatomy captured in the original CBCT and diagnostic cast.
Any dental or gingival changes invalidate the guide — a new scan and guide are required.

Limitations of Liability

Implant Concierge® products must be used only as recommended and with compatible systems.
Improper use, off-label applications, or third-party modifications void any warranty or liability.
The clinician is responsible for appropriate case selection, procedural judgment, and adherence to current implantology standards.
The surgical protocol should be fully understood before using the surgical guide.

If clarification is required for the protocol, contact our Customer Service Team at 866-977-2228 or support@implantconcierge.com.

Reporting/Product Experience Policy

Implant Concierge® stands behind our services and products. If at any time, you believe that an Implant Concierge service or product did not meet reasonable expectations, please let us know.*

As an FDA-registered facility, we follow a strict Quality Management System, which includes detailed documentation of complaints and product experiences.

* Click here to review the Product Product Experience Policy