Инструменты для установки стоматологических имплантатов: наборы инструментов для системы имплантационной стоматологической BLUEDIAMOND Implant System:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

MegaGen Implant Co., Ltd., РЕСПУБЛИКА КОРЕЯ

класс:

изделия медицинского назначения

Производитель:

MegaGen Implant Co.

Дата Авторизация:

2023-10-12

Характеристики продукта

Surgical Instrument
www.imegagen.com
MegaGen Implant Co., Ltd
45, Sechen-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu 42921,
Republic of Korea
Tel. [phone] / Fax. [phone]
Europe representative : MDSS GmbH
Schiffgraben 41 30175 Hannover, Germany
● CE conformity marking
● Catalogue number
● Batch code
● Date of manufacture
● Serial number
● Non-sterile
● Temperature limitation
● Caution, consult accompanying documents
● Do not use if package is damaged
● Manufacturer
● Consult instructions for use
● Authorised representative in the european community
Rx
Only
● Caution: Federal law(USA) restricts this device to
sale by or
on the order
of
a licensed dentist
IFU-II-R10/ 20-08-28
English
1. Product Summary
To
recover
a
patient’s
masticatory
function,
it
is
necessary to have a dental implant which is implanted
into a patient’s alveolar bone as a root of a tooth
and abutment which is protruded through the gum in
the
oral
cavity.
These
products
include
various
Instruments to support implant surgery.
2. Intended Use
These products are surgical instruments designed for
the
surgical
placement
of
dental
implants
or
prosthesis.
It
typically
contain
various
dental
drills,
drill
extensions,
depth
gauges,
wrenches,
drivers,
osteotomes,
path
finders,
and
direction
indicators
designed in various types and sizes for use.
※ Surgical insertion instruments for temporary use(like
Drill etc.)
→
All
surgically
invasive
devices
intended
for
transient use
Surgically invasive devices that perform for creating
hard tissue/ soft tissue shapes suitable for implant
surgery,
like
to
drilling
holes
on
the
bone
cutting
tissue.
Product lines are as follows:
- Lance drill
- Tissue Punch
- Marking Drill
- Shaping Drill
- Stopper Drill
etc.
※ The Instruments that is not inserted surgically(like
Connector, Driver etc.)
→ only to assist in the procedure
Surgical non-invasive devices that perform to help for
implant surgery
and
don't
modify hard
tissue/
soft
tissue.
Product lines are as follows:
- Handpiece C