Surgical Guide Instructions for Use (IFU)

Overview: This article provides instructions for the sterilization, handling, and clinical use of Dandy’s 3D-printed surgical guides for dental implant surgery.

Surgical Guide Indications and Contraindications

The surgical guide is a disposable, patient-specific medical device intended for intra-oral use during guided dental implant surgery.

Contraindications for the Surgical Guide:

  • Uncontrolled systemic diseases (diabetes, immune issues, clotting disorders).

  • Heavy smoking or insufficient bone.

  • Specific medications (bisphosphonates, blood thinners).

  • Uncontrolled bruxism or pregnancy.

Prepare the Surgical Guide for Sterilization

Follow these cleaning and inspection steps before placing the surgical guide in the autoclave:

  1. Clean the Surgical Guide: Remove all visible soil. You may wipe the surface with alcohol.

  2. Dry the Surgical Guide: Use compressed air to dry all hollows and complex geometries.

  3. Inspect the Surgical Guide: Check for cracks or damage. If damaged, replace the surgical guide immediately.

  4. Package the Surgical Guide: Use single or double sterilization pouches resistant to at least 137°C (279°F). Place labeling only on the non-porous side of the pouch.

Sterilize the Surgical Guide

Place the packaged surgical guide on its edge in the autoclave chamber to ensure proper steam penetration and drying.

United States Steam Sterilization Parameters:

Parameter Setting
Sterilizer Type Pre-vacuum
Preconditioning Pulses 4
Temperature 132°C (269.6°F)
Full Cycle Time 4 minutes
Dry Time 30 minutes

Handle and Store the Surgical Guide

  1. Cooling: Allow the surgical guide to cool completely within the sterilizer load before handling.

  2. Storage: Store the packaged surgical guide in a dry place at room temperature (18–25°C / 64–77°F).

  3. Usage Limits: The surgical guide is for single use only. Do not reuse or resterilize the surgical guide, as it may compromise material integrity.

Insert the Surgical Guide

  1. Wash your hands thoroughly.

  2. Insert the surgical guide onto the patient’s teeth, starting from the back and moving forward.

  3. Gently press the surgical guide onto the teeth with your fingers to ensure a snug fit.

ADA Codes

Surgical Appliances
D7286 Surgical Stent
D7971 Tooth or Tissue-Supported Surgical Guide
D7286 Placement of guide for dental implant surgical stent
D7971 (CAD/CAM) surgical guide for dental implant placement
D9944 Occlusal orthotic device, surgical guide
D5934 Mandibular resection prosthesis with guide flange
D5935 Mandibular resection prosthesis without guide flange
D3432 Guided tissue regeneration, resorbable barrier, per site, in conjunction with periradicular surgery
D4266 Guided tissue regeneration, natural teeth—resorbable barrier, per site
D6106 Guided tissue regeneration (resorbable barrier) per implant

Related Information

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