INSTRUCTIONS FOR USE (IFU) - Australia Patient Matched Medical Device (PMMD)
Device Family: Bridge - Polymer
GMDN: 37542
Product Code(s): PMMASBRA, PMMASBRP
Manufacturer:
Zima International, Inc. Also DBA Dandy
1320 N. 300 W.
Lehi, UT 84043
United States
Contact:
Australian Sponsor
Name = DANDY Labs AUS Pty Ltd
Registered Address = Tower One - International Towers, Level 46, 100 Barangaroo Avenue, Sydney, New South Wales 2000 Australia
Intended User: Prescriber Dental professional / dental practice
Device Type: Patient Matched Medical Device (PMMD)
Sterility: Not supplied sterile (if applicable)
Single-use / Reusable: Single-use
1) Intended Purpose (Intended Use)
Dandy’s temporary bridges are made to provisionally restore worn, carious, broken, and aesthetically unpleasing dentition.
They:
- 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.
- Provide a preview of the final restoration.
2) Device Description / Key Specifications
- Custom-made, patient-specific device manufactured per dental professional prescription and digital input data.
- Configuration: Dandy’s temporary bridges (PMMA) 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. PMMA, which stands for polymethyl methacrylate, is not intended for short-term use.
- Material: Argen PMMA
Temporary Crown and Bridge Material Safety Data Sheet
3) Contraindications
Temporary crowns should be used with caution in patients with uncontrolled periodontal disease, severe bone resorption, active caries, or oral lesions.
4) Warnings / Precautions / Potential Risks
The use of temporary bridges may have potential risks, including failure, misfit, breakage, and recurrent caries.
*Warning – Irritation:
- Localized irritation of surrounding oral tissues may occur in specific individuals due to individual variability in tissue response. Patients should be monitored after placement, and the treating clinician should assess any signs of irritation, inflammation, or discomfort.
5) Cleaning and Care (Patient Care Instructions — as directed by the dental professional)
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). Care must be taken to prevent the dislodging of the restoration.
- Mouthwash:
- Alcohol-based mouthwashes tend to dry out the mouth, leading 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, as they can form new cavities or cause premature decay of the restorative margins.
- Stay hydrated: Drinking plenty of water helps keep your patient’s mouth clean and prevents gum disease.
- Avoid bad habits: Refrain from using teeth to open packages or biting on hard objects.
6) Storage
Requires a cool, dry place, protected from direct sunlight, extreme heat (above 77°F/25°C), moisture, dust, and contamination, as these conditions can degrade the material or compromise its integrity, affecting temporary use and ultimately impacting shelf life and performance.
7) Expected Life / Service
PMMA (polymethyl methacrylate) dental bridges generally last 3 to 5 years, but often require more frequent attention than other materials, depending heavily on oral hygiene, habits (avoiding hard/sticky foods), bridge design, and location (front vs. back teeth).
8) Incident / Complaint Reporting
Report suspected serious incidents associated with this device to:
- The Manufacturer and/or Dandy Australia entity using the contacts above, and
- Therapeutic Goods Administration (TGA)
9) Disposal
Disposal of PMMA (Polymethyl Methacrylate) dental restorations involves recycling, often through specialized dental waste handlers who can chemically break it down into its monomer (MMA) or manage it as plastic. However, it should not be placed in the general trash due to environmental concerns.
- Fully cured PMMA might also be treated like general plastic waste if not mixed with metals or hazardous components.
- No Regular Trash: Do not dispose of PMMA dental waste in the regular garbage or medical waste streams.
- Hazardous Components: If mixed with solvents or other hazardous materials, it requires specific hazardous waste handling.