Indications for Use
Dandy's surgical guide is a disposable medical device customized (3D-printed) for a single patient.
It is indicated for intra-oral use in guided dental implant surgery by a dental professional.
The 3D-printed medical device requires steam sterilization before use in surgery via
the validated process entailed below.
Contraindication
A validated sterilization process renders the medical device free from viable
microorganisms. Note that in a sterilization process, the nature of the microbial death
is expressed in terms of probability, and although it is reduced to a very low number, it can
never be reduced to zero.
Pre- Sterilization
CLEANING
Thoroughly remove any visible soil remaining on the surface. Alcohol can be used to wipe the
surface of the surgical guide to ensure a clean part results from this process. No contamination
shall be found by the naked eye or felt by running fingers on the surface of the part. Special attention
should be given to edges, hollows, and other geometries.
DRYING
Dry the part, especially in the hollows and geometries. Compressed air can be used for air drying.
INSPECTION
Once dried, inspect the medical device for damage or cracks. Replace the part if needed.
PACKAGING
Only use sterilization pouches in compliance with the requirements according to DIN EN ISO 11607/
ANSI/AAMI ST79/AAMI TIR12:2010, e.g. disposable sterilization packages (single or double packages)
temperature-resistant up to at least 137 °C (279 °F) and sufficient steam permeability.
Follow the instructions for use provided by the packaging manufacturer when packaging the medical
device prior to sterilization. Any labeling should be placed or written on the non-porous side of the
pouches. When sealing, pouch seals should be smooth and free from bubbles, wrinkles, and folds.
Paper-plastic pouches containing the medical device should not be placed within wrapped sets or
containment devices.
Consult the instructions for use provided by the sterilizer manufacturer regarding the use of any
sterilizer accessories. Sterilizing equipment should have demonstrated efficacy (e.g. FDA clearance,
EN 13060 or EN 285 compliance).
STERILIZATION
Note: Packaged medical devices must be placed on edge to prevent the collection of condensate
that could impede device and package drying and to ensure appropriate exposure of the
medical device to the sterilant. Place the packaged medical devices in the chamber in a manner
that allows for adequate air removal, penetration of steam into each package, and steam
evacuation. Follow the steam autoclave processing directions for your region per the parameters below. See the table below.
PROCESSING PARAMETERS FOR THE UNITED STATES AND COUNTRIES
FOLLOWING THE US STEAM STERILIZATION GUIDELINES:
Sterilizer Type: Pre-vacuum
Preconditioning Pulses: 4
Temperature: 132°C
Full Cycle Time: 4 minutes
Dry Time: 30 minutes
Test Article Configuration: Individually double-pouched in 5.5” x 10” and 7.5” x 13” pouches (Cardinal Health self-sealed pouch CAT #92713-510(k) K153540); packaged test articles placed on the edge of the chamber.
Post-sterilization handling instructions
After the medical device is exposed to the full sterilization set points, allow the device to cool
with the sterilizer load. The packaged devices should not be handled prior to cooling. A minimum
drying time of 30 minutes is recommended; longer drying times may be required depending on the
equipment, loading configuration, and ambient conditions present in the sterilization area.
Storage instructions
The products should be stored, in their package, in a dry place, at a normal temperature
(18–25°C/64–77°F). Use the sterilized components within the stated time period from the sterile bag
manufacturer.
Product single use indications:
Do not reuse
When “do not reuse” non-sterile devices are supplied and require sterilization prior to usage, the appropriate sections in these guidelines may be applied.
Do not resterilize
Devices are not designed to perform as intended after the first usage or an additional sterilization
process. Changes in mechanical, physical, or chemical characteristics introduced under certain conditions
of repeated use, cleaning, and/or resterilization may compromise the integrity of the design and/or
material, leading to diminished safety, performance, and/or compliance with relevant specifications.
Directions for Use
To ensure the proper use of the device, dental professionals should follow these steps:
- Wash your hands thoroughly before handling the device.
- Carefully insert the device into the patient’s teeth, starting from the back of the patient’s mouth and working forward.
- Use your fingers to gently press the device onto the patient’s teeth to ensure a snug fit.
Additional Information
ADA Codes
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Surgical Appliances
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Material Safety Data Sheets (MSDS)
Please see the attached Surgical Guide Safety Data Sheets for additional information.