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The package includes:
1 sterile implant
1 sterile impression coping transfer
1 burnout cap
Instructions for Use
Basalfix outer packaging is made of cardboard and features a useful tearoff opening system. The packaging design shows the indications regarding the implant line name: Basal, Compressive or TPI.
The external labels are distinguished by the colour coding:
O Blue: Basal Line
O Green: Compressive Line
O Yellow: TPI Line
The sticker contains also all the specific data of the implant: description, reference number, production batch, sterility expiration date and manufacturer.
Inside the pack there is the sterile tube containing the implant and the plastic impression coping, the plastic analogue, the burnout cap, the instructions for use and 3 stickers with description, reference number and production batch of the implant, which must be applied on the patient’s medical record, on the implant passport given to the patient and on any further documentation.
The primary packaging of Basalfix implants is performed in an ISO 7 type cleanroom to avoid any contamination, in compliance with the sectorial norms.
Basalfix medical devices are manufactured according to the European Directive 93/42/EEC, the manufacturer was entitled to sell by a European body and guarantees a quality system ISO 9001 and ISO 13485 since 1998.
Basalfix is a dental implant system completely developed and manufactured in Italy, using only certified medical materials sourced from referenced suppliers.
All Basalfix implants are made of high strength Titanium Grade 4, according to ASTM F 67 norm.
Various lengths and diameters are available in order to adapt to various clinical cases. They are indicated for multiple rehabilitation only, for both flap and flapless techniques.