Retainer Thermoformed Instructions for Use (IFU)

Overview: This guide provides the instructions for use, clinical indications, cleaning protocols, and clinical adjustments for the Dandy thermoformed removable retainer.

Understand Indications and Risks

Indications for Use

The removable retainer is a clear plastic device used after orthodontic treatment. It maintains the position of the teeth and prevents shifting to ensure treatment results are preserved.

Contraindications

Do not use the retainer if the patient has a known plastic allergy or dental conditions that prevent the safe wearing of a removable device.

Potential Risks

The retainer can break or crack if handled improperly. Avoid chewing on the retainer or exposing the retainer to excessive heat.

Apply the Retainer

  1. Wash your hands thoroughly with soap and water before handling the retainer.

  2. Insert the retainer into the patient's mouth.

  3. Start at the back of the mouth and work forward toward the front teeth.

  4. Press the retainer gently with your fingers to ensure a snug fit over the teeth.

Maintain and Clean the Retainer

Daily cleaning is required to maintain the device.

  1. Use a soft-bristled toothbrush and non-abrasive toothpaste.

  2. Brush the retainer gently on all surfaces.

  3. Rinse the retainer thoroughly with cool water.

  4. Store the retainer in its provided case when not in use.

  5. Keep the storage case in a cool, dry place away from direct sunlight.

 

Note: Never use hot water or mouthwash, as these can warp or discolor the plastic material.

Perform Clinical Adjustments

Clinicians should use the following method to prevent micro-fractures during adjustment:

  • Method: Use a high-speed handpiece with minimal pressure.

  • Cooling: Always use water and air spray to maintain temperature.

  • Tools: A fine-grit diamond bur is recommended. Do not use an air-only handpiece.

Select Proper Burs

  • Occlusal and Lingual surfaces: Use a football-shaped bur.

  • Buccal and Lingual surfaces: Use a tapered bur.

Follow Recommended Wear Times

Wear times may vary by clinician, but Dandy recommends the following schedule:

  • Months 1–6: Wear the retainer for 22+ hours per day. Only remove the retainer to eat, brush, or floss.

  • Years 1–2: Wear the retainer only during sleep.

  • Year 3 onwards: Wear the retainer every other night for life.

Additional Information

Clinical studies have shown removable retainers to be an effective and reliable treatment option for patients looking to protect their orthodontic work. If the patient experiences any adverse events, such as pain or irritation, they should discontinue use and contact your practice immediately. Removable retainers come with a limited warranty, which may vary depending on the manufacturer.

ADA Codes

Orthodontics
Clear Aligners D8090 Comprehensive Adult ortho
Orthodontic retention  D8680 This code is all-encompassing to any orthodontic retention
Orthodontic retention (Single Arch) D8680 This code is all-encompassing to any orthodontic retention
Orthodontic retention  (Double Arch) D8680 This code is all-encompassing to any orthodontic retention
Clear Aligners  D8040 Limited orthodontics of adult dentition

Related Information

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