For a correct use of EasyPiece® we recommend to take note of this information and of the instructions for use which are available on our website www.overmed.eu in the dedicated section (Ref. European Regulation n. 207/2012). Information about our products can also be provided verbally, in writing, by e-mail or through practical demonstration at our centers. The choice of the device, its suitability for the clinical situation, as well as the implementation of the correct surgical procedure is responsibility of the user. The user should be continually up to date on the development and application of EasyPiece®, particularly in the case of use of the product in proceedings not expressly recommended. If you have any doubt, we recommend to contact the manufacturer.
EasyPiece® is provided exclusively for accredited professionals in the dental sector who are responsible for use of the product. The manufacturer is excluded from any liability for damages caused or produced by an incorrect use of the product. EasyPiece® system should be solely used with components and tools belonging to this system. The use of elements outside of the EasyPiece® system could prejudice functionality of the system itself.
Errors and inaccuracies in patient assessment, diagnostics and treatment planning could lead to loss of the implant. EasyPiece® is subjected to continuous development and the manufacturer reserves the right to changes to the design and production of EasyPiece®.
Choice of the Fixture
The number and type of fixtures to be implanted depends on many factors including quality of the bone in which to place the fixture, thickness of the bone, the situation of the implant site, local mastication force, etc.
It is recommended to evaluate all these factors before choosing the system.
EasyPiece® dental fixtures, which are indicated for all cases of aesthetic and functional restoration, are inserted into the dental arches of fully or partially edentulous patients. The fixtures should be used in a minimum number of four following the instructions given in the surgical protocol.
EasyPiece® dental fixtures, are contraindicated in the following cases:
Insufficient quantity of bone tissue, the presence of chronic or acute infections, systemic diseases, subacute chronic maxillary osteitis, diseases involving microvascular disorders; it is also not recommended to use the fixtures in patients who are unwilling to collaborate, who are abusing drugs or alcohol or who have a poor oral hygiene.
Side Effects and Interactions
Patient should stay at rest and avoid heavy physical activity for at least two days after surgery.
Advise in the case of onset of pain and complications, to immediately consult the dentist or surgeon.
Loss of bone on the ridge (top and bottom), irreversible damage to contiguous or antagonist teeth, persistent pain due to the fixture, bone fracture, fracture of the fixture or superstructure; oroantral and oronasal fistulas, esthetic problems.
A risk of failure, despite the very high percentage success rate, may be present and its causes are not easily detectable. They must nevertheless be researched and documented such as: poor quality and quantity of bone, infection, poor dental hygiene, incorrect surgical protocols and poorly distributed prosthetic loads.
All cases of failure must be communicated to the manufacturer in order to activate product improvement, if necessary, and reduce the risks connected with product use.