Instructions for use SURGmatic S201 XL Pro - 1.013.7541 SURGmatic S201 L Pro - 1.013.7540
3 Product description | 3.1 Intended use
3 Product description
SURGmatic
S201 XL Pro
SURGmatic S201 XL Pro
Mat. no. 1.013.7541
SURGmatic
S201 L Pro
SURGmatic S201 L Pro
Mat. no. 1.013.7540
The SURGmatic (S201 L/XL Pro) handpieces are electrically driven dental hand-
pieces according to 21 CFR § 872.4200 (dental handpieces and accessories) for
use by a professional trained in the field of general dentistry. The devices are
electrical-powered handpieces that are reusable and ergonomically shaped, and
provided with a fiber optic light system. The devices can be sterilized by the
steam autoclave method. Through a surgical motor connected to the surgical
control unit, the handpieces, equipped with a handpiece connection according
to ISO 3964, receives the energy, the cooling water and air for treatment and
the light for illumination the operation area. Surgical burs and cutters (with
straight handpiece shank or with contra-angle shank) according to ISO 1797
can be used. The handpieces use external spray allowing external irrigation to
the working area. Based on the speed adjusted in the surgical control unit the
handpiece bur rotates up to 40,000 rpm. The handpieces interacts with the pa-
tient through a rotating bur with the patient teeth according to the intended
use.
3.1 Intended use
Indications for use:
This medical device is
▪ intended for dental treatment only. All other types of use or modifications of
the product are not permitted and can be hazardous. The medical device is
intended for use in the following applications: surgery e.g. placing an im-
plant, bone augmentation, sinus lift, dental extraction, implantology and
oromaxillary and facial surgery.
▪ A medical device in accordance with the relevant national statutory regula-
tions.
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
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