INSTRUCTIONS FOR USE (IFU) - UK CUSTOM-MADE DEVICE (CMD - Custom Made Device)
Device Family: Partial Denture
GMDN: 17845
Product Code(s): ACRPARDENT, ACTLPARDENT, CCPARDENT, DURPARDENT, TITPARDENT, TRYPARDENT, VALPARDENT, PDWAXRIM, PDHYBRID
Manufacturer:
Zima International, Inc. Also DBA Dandy
1320 N. 300 W.
Lehi, UT 84043
United States
Contact:
UK Responsible Person (UKRP):
Name = DANDY LABS GB, LTD
Company Number = 16873608
Registered Address = 5 New Street Square, London EC4A 3TW.
Intended User: Prescriber Dental professional / dental practice
Device Type: Custom-made dental device (CMD)
Sterility: Not supplied sterile (if applicable)
Single-use / Reusable: Reusable
1) Intended Purpose (Intended Use)
Partial dentures are a type of removable dental prosthetic device used to replace one or more missing teeth. They are typically made of either a metal, acrylic, or a flexible framework with replacement teeth that are attached to an acrylic base, which is colored to match the gums
2) Device Description / Key Specifications
- Custom-made, patient-specific device manufactured per dental professional prescription and digital input data.
- Configuration: Dandy acrylic partial dentures are custom-made to fit your mouth and are designed to be as comfortable and unobtrusive as possible.
- Material: Chrome Cobalt, Titanium, Acrylic, TCS, Valplast, Duraflex, Acetal, PMMA
Partial Dentures Material Safety Data Sheets
3) Contraindications
Partial dentures should not be used if you have any allergies to acrylic, plastic,/or certain metals. Partial dentures should not be used in patients who have severe gum disease.
4) Warnings / Precautions / Potential Risks
Risks include sore spots, discomfort, and possible damage to remaining natural teeth.
5) Cleaning and Care (Patient Care Instructions — as directed by the dental professional)
Directions for Use
- To ensure proper use of acrylic partial dentures, follow these steps:
- Ensure that the partial denture is clean and free of any debris.
- Rinse the patient’s mouth with warm water before inserting the partial denture.
- Gently place the partial denture in the mouth, and use your fingers to guide it into place.
- Avoid using excessive force or pushing the partial denture too far.
- Instruct the patient to gently bite down on the partial denture to ensure proper fit and stability.
- Use carbon articulation paper to adjust any heavy occlusion points.
- Provide specific instructions to the patient on how long to wear it each day and when to remove it.
Cleaning instructions
- Dandy recommends cleaning your partial dentures daily before and after every use. Immediately after removal, use warm water (not to exceed 45°C/113°F) and soap to remove remaining saliva and debris from your partial dentures.
Avoid
- Soaking your partial dentures in any liquid for longer than the manufacturer of the cleaning solution recommends.
- Soaking your partial dentures in hard water. Over time, exposure to tap water containing elevated chlorine levels could tarnish the metal.
- Do not immerse your partial dentures in water exceeding 45°C/113°F to prevent warping.
- Use only approved cleaners for meta/acrylic/flexiblel partial dentures and avoid abrasive toothpastes, as they can damage the device's appearance.
- Soaking your partial dentures in a bleach-based cleaning solution this may tarnish them.
Do
- Dispose of the cleaning solution after every use. Rinse your partial dentures well before use.
6) Storage
Store the partial dentures in a clean, dry place when not in use. Avoid exposing partial dentures to excessive heat or pressure, as this may cause warping or other damage.
7) Expected Life / Service
Partial dentures are designed to last several years with proper care and maintenance. Patients should contact the dental practice for evaluation and repair if dentures become damaged or lose fit.
8) Incident / Complaint Reporting (UK)
Report suspected serious incidents associated with this device to:
- The Manufacturer and/or UK Responsible Person (UKRP) using the contacts above, and
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with local requirements.
9) Disposal
- Partial denture disposal usually involves handling it as regulated biohazardous or general waste, often via specialized handlers for incineration or secure landfill.
- Always avoid putting them in regular trash without checking local rules.
- Biohazard/Infectious Waste: Treat used or unclaimed dentures as biohazardous due to saliva/blood; use red bags and authorized carriers.
- Incineration: A common method for final destruction.
- Confidentiality: Redact or destroy patient info on lab boxes and bases before disposal.