ProTaper® Universal FOR DENTAL USE ONLY DIRECTIONS FOR USE PROTAPER® UNIVERSAL A0409 - A0410 - A0411 - A0415 PROTAPER® INSTRUMENTS FOR ENDODONTIC TREATMENT: • ProTaper® shaping files • ProTaper® finishing files The cutting part of these instruments is made of a nickel-titanium alloy. 1) INDICATIONS FOR USE These instruments are to be used only in a clinical or hospital environment, by qualified users. Application field: shaping and cleaning of the root canal system. None known. 3) WARNINGS This product contains nickel and should not be used for individuals with known allergic sensitivity to this metal. 4) PRECAUTIONS • Multiple use disinfection and resterilization cycles may lead to increased risk of file separation. • These instruments should not be immersed in a sodium hypochlorite solution. • Instrument decontamination: strictly follow decontamination instructions from the manufacturer. • Irrigate abundantly and frequently. • Establish a reproducible glide path using hand files, at least an ISO 015 size. • Use in a constant rotation at a speed of 250-350 rpm with light apical pressure. • Clean flutes frequently and check for signs of distortion or wear. • For optimal usage, torque control devices are recommended. • Use the Shaping Files (S1, S2 and SX) with a brushing action on the withdrawal stroke in order to create straight line radicular access.

• Use the Finishing Files (F1, F2, F3, F4 and F5) with no brushing action. • Use the appropriate finishing files to passively follow the canal to the working length, and then withdraw immediately. In the present technical state, no adverse reaction has been reported so far. 6) STEP BY STEP INSTRUCTIONS FOR PROTAPER® FILES 1) Create straight line access to canal orifice. 2) Always irrigate and confirm a reproducible glide path with an ISO 015 hand file. 3) Protocol of use: • ocate the orifice. L • Use passively an ISO 015 hand file to resistance. • Use Shaping File S1 with brushing action until...

4) Use only a detergent solution, with disinfecting effect, which is approved for its efficacy (VAH/DGHM-listing, CE marking, FDA approval) and in accordance with the DFU of the detergent solution manufacturer. For all metal devices, it is recommended to use anticorrosion disinfecting and cleaning agents. 5) For your own safety, please wear personal protective equipment (gloves, glasses, mask). 6) The user is responsible for the cleaning and sterilization of the product for the first cycle and each further usage as well as for the usage of damaged or dirty devices where applicable after sterilization....

Maillefer Instruments Holding Sarl Chemin du Verger, 3 CH-1338 Ballaigues Switzerland www.dentsplysirona.com