Fixed Restoration IFU

Jon M, DDS

Updated December 30, 2025 19:44

Dandy’s fixed restorations are fabricated using digital technology, allowing for a precise fit and customization to the patient's specific needs. They are made of a highly durable and biocompatible material, ensuring long-term comfort and function.

Indications for Use

Dandy’s fixed restorations are made to restore worn, carious, broken, and aesthetically unpleasing dentition.

They:

Restore single, permanent teeth (crowns) that are fractured, carious, discolored, or severely worn.
Replace one or more missing permanent teeth (bridges) by spanning the edentulous space and being supported by natural teeth or dental implants.
Restore the form, function, and esthetics of natural dentition.
Provide occlusal stability and maintain proper interarch relationships.

Contraindication

Fixed restorations should be used with caution in patients with uncontrolled periodontal disease, severe bone resorption, or oral lesions.

Potential Risks and Benefits of Fixed Restorations

Advise patients of the following

The use of fixed restorations may have potential risks, including failure, misfit, breakage, and recurrent caries.

**Warning – Sensitivity:
- This device contains trace levels of cobalt and chromium oxides used as colorants in the ceramic material. Patients with sensitivity or allergy to cobalt or chromium should be informed by the treating clinician of the presence of these compounds in the device prior to treatment. In rare cases, allergic reactions may occur in sensitized individuals.
**Warning – Irritation:
- Localized irritation of surrounding oral tissues may occur in certain individuals due to individual variability in tissue response. Patients should be monitored post-placement, and any signs of irritation, inflammation, or discomfort should be evaluated by the treating clinician.

However, the benefits include improved speech, comfort, appearance, chewing, and digestion.

Restoration and Cementation

Test fit all restorations to ensure adequate fit and aesthetics
Take x-ray if margins are not visible to ensure proper adaptation
Adjust high spots (using articulating paper to mark areas)
Cementation of restoration
- Zirconia Restorations
  - Bond zirconia crowns using a chemical and mechanical pretreatment protocol, such as air-particle abrasion and tribochemical silica coating.
    - The practice will need to sandblast and steam-sanitize all zirconia restorations.
  - Utilize zirconia-specific primers, especially those with 10-MDP, for chemical bonding.
  - Please see: Zirconia Cementation and Adjustment Guidelines, for more information.
- Emax Restorations
  - Versatile cementation choices are available with e.max restorations. Crowns and bridges can be cemented using adhesive, self-adhesive, or conventional methods. Inlays, onlays, and veneers are typically cemented adhesively.
  - Lithium disilicate restorations require etching before placement.
  - For adhesive and self-adhesive cementation of IPS E.Max, silanize restorations are necessary.
  - Please see: Comprehensive Guide to Cementation of E.Max Restorations, for more information.
- Metal Restorations
  - Metal crowns require air abrasion with alumina particles for enhanced adhesion.
  - Tooth pretreatment
  - Please see: Full Metal and Porcelain Fused to Metal (PFM) Cementation and Adjustment Guidelines, for more information.

Cement recommendations

Adjustment recommendations

Operate the bur at high speed, applying minimal pressure while using water.
- It's important to maintain the temperature using water and air spray. This method helps prevent the formation of micro-fractures. A fine-grit diamond is advisable for adjustments, and air-only handpiece adjustments are not recommended.
- For shaping different surfaces, specific tools are best:
  - A football-shaped bur is effective for the occlusal and lingual surfaces, especially on anterior teeth
  - A tapered bur is better suited for the buccal and lingual surfaces.

Daily Cleaning

Oral Hygiene:
- Brushing:
  - Recommended brushing teeth twice a day, using a soft-bristled toothbrush and a fluoride toothpaste.
- Flossing:
  - Recommend daily flossing to remove plaque and debris from between the teeth and around the fixed restoration. A floss threader may be needed for hard to reach areas (for bridges).
- Mouthwash:
  - Alcohol-based mouthwashes, tend to dry out the mouth and lead to increased plaque and tartar buildup.

Dietary and Habit Recommendations

Avoid abrasive foods: Limit hard, crunchy, or sticky foods that can damage the restoration or cause it to loosen.
Avoid sugary foods: where new cavities can form or cause premature decay of the restorative margins.
Stay hydrated: Drinking plenty of water will help keep your patient’s mouth clean and prevent gum disease.
Avoid bad habits: Refrain from using teeth to open packages or bite on hard objects.

Additional Information

If the patient experiences any adverse events, such as pain or irritation, they should contact your practice immediately.
Fixed restorations have a limited warranty, which may vary depending on the manufacturer.
Smoking with restorations can cause discoloration

Disposal

Disposing of restorations depends on the type: full-metal and metal-fused-to-porcelain should go to a dental scrap refiner for precious metal recovery. In contrast, all-ceramic (porcelain) restorations often go with regular solid waste or to specific recycling centers that take mixed ceramics/construction debris, as they're hard to recycle like typical items. Always check with your local municipality or waste hauler for specific rules, but generally, ceramic items are not for standard curbside recycling bins.
For Metal or Precious Metal restorations (PFM, Gold)
- Dandy asks that restorations that contain precious metals created by Dandy that need refabrication, be returned to us.
- Dental Scrap Refiners:
  - Companies specialize in recovering valuable metals from dental scrap.
  - They often provide containers for dental offices (or individuals) to mail in scrap for processing, offering payment for the recovered metals.
- Hazardous Waste:
  - Some dental waste is hazardous (that which has been in contact with saliva), but metal restorations themselves are usually non-hazardous, just valuable.
For All-Ceramic (Porcelain) restorations
- Household Trash:
  - Place them |in your regular garbage bin, as they don't break down in standard recycling.
- Recycling Centers:
  - Take them to a local recycling center that accepts mixed ceramics, concrete, or construction debris, as they can sometimes be repurposed.
Identify Material:
- Determine if it's all ceramic or fused to metal.
Check Local Rules:
- Contact your local sanitation department or waste hauler
Find a Specialized Recycler:
- For precious metals, find a dental scrap refiner; for porcelain, a mixed-material recycling center.

ADA Codes

Multiple codes are available
Please consult with a CDT for recent information.

Material Safety Data Sheets (MSDS)

Attached are the Material Safety Data Sheets for our Fixed Materials.

Laboratory Supplied IFUs:

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