Extractor

Dénomination commerciale

Extractor

06947600316763

069476003001301EJ

Numéro de référence/catalogue

MDR 818098 R000

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Regular Guide，long

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• L159099ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 1.Use with caution if allergic to stainless steel or titanium materials. 2.Use with caution in patients whose implants have failed as assessed by imaging. 3.Professional training is strongly recommended for the safe and effective use of Bioconcept instruments, which are highly specialized and complex procedures. Improper operations may result in a preparatory hole failure, resulting in an implant failure. 4.Repeated disinfection and sterilization may increase the risk of device failure. 5.The instruments must be cleaned, disinfected, and sterilized again before use, and the instruments shall be used immediately after sterilization. 6.Before use, ensure that instruments are securely attached to the dental handpiece or wrench and do not fall off when shaken. 7.Instruments that are not securely attached to the dental handpiece or wrench must be secured against aspiration when used intraorally. A ligature, rubber dam or throat pack can be used for this purpose. Do not use damaged or blunt instruments. Always inspect instruments before use. Never clean instruments with metal brushes or steel wool. 8.The specifications of the BV Extractor instruments must match those of the implant; see the specification list for details. Otherwise, removal failure is likely to occur. 9.Instruments from dirty to clean, no cross, no countercurrent, air flow from clean to dirty; The decontamination area maintains relative negative pressure, and the inspection, packaging and sterilization area maintains relative positive pressure. (meets the requirements of WS310 or ANSI AAMI ST79 or EN ISO17665)

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