Dental Direkt DD Bio Splint Flex Medical Polycarbonate Instruction Manual
- June 1, 2024
- Dental Direkt
Table of Contents
Dental Direkt DD Bio Splint Flex Medical Polycarbonate
Material-related characteristics
- Chemical composition [wt.%]
- Copolyester (PCT-G) 100
Physical specifications
Explanation of symbols
Caution
U.S. Federal law restricts this device to sale by or on the order of a
dentist.
Indications
DD Bio Splint FLEX are transparent dental milling blanks made of copolyester, for the manufacture of flexible splints, therapeutic splints, bite regulators and drilling templates, for short-term use in the oral cavity of up to 30 days.
Contraindications
- intolerance to the contained components
- crowns, bridges, model casting with clasps, bars, narrow sublingual bars and transversal connectors
Safety information
Please take note of the information in the latest version of the safety data
sheet. Avoid the inhalation of milling dust during processing. Wear gloves,
protective goggles and a face mask to avoid skin irritation.
Handling and storage
The medical device may only be processed by trained personnel. Only use clean,
defect-free material from undamaged packaging and ensure that the blanks are
stored at room temperature, in their original cartons, in a dry location and
protected from light. Avoid all contact with fluids.
Milling and further processing
Milling must be performed using a milling strategy that is aligned with the
material. Only use one-edged milling tools in the milling machine or wet
grinding procedures!
Further processing
Carbide cutters with FSQ toothing and black ring cutters are well-suited to
the rough cutting for titanium. The fine post-processing can be performed
using simple, cross-toothed HM cutters. The retaining bars are removed
carefully and without high pressure. It is possible to polish the material;
however, the contact pressure should be kept as low as possible since the
resulting heat could otherwise result in smearing or melting.
Cleaning
- ultrasonic bath (max. 40 °C) with a gentle cleaning agent
- Disinfection with IPA or med. Disinfectants
- Gamma and ETO sterilization possible
- Do not use the following methods for cleaning:
- steam blasting
- autoclave method (e.g. sterilization/disinfection)
- organic solvents and acids (e.g. acetone, hydrochloric acid)
- highly concentrated alcohols
- chemical denture cleaners
- abrasive cleaning agents
Disposal
Remains of copolyester blanks can be disposed of in the regular household
garbage. Our devices are subject to strict quality controls and reflect the
current state of technology. We are continuously enhancing our devices and
therefore reserve the right to make changes. The latest version of the
instructions for use can be found on our website at:
www.dentaldirekt.de/en. This version replaces
all previous versions.
Dental Direkt GmbH Industriezentrum 106-108 32139 Spenge Germany Tel. 0049
5225 863190 2 / 2
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>