Материал стоматологический пломбировочный на основе полимера: материал стоматологический реставрационный универсальный Filtek

Country: Belarus

Language: Russian

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

Available from:

3M ESPE Dental Products, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Class:

изделия медицинского назначения

Manufactured by:

3M ESPE Dental Products

Authorization date:

2020-02-06

Summary of Product characteristics

Instructions for Use
Инструкция по применению
Указания за употреба
Upute za upotrebu
Használati utasítás
Instrukcja użycia
Instrucţiuni de utilizare
Návod na použitie
Navodila za uporabo
ENGLISH
GENERAL INFORMATION
Filtek™ Universal Restorative is a visible-light activated
restorative
composite optimized to create esthetic anterior and posterior
restorations. The shades are body like opacity enabling up to a 2 mm
depth-of-cure. The pink opaquer can be placed in 1 mm thick
increments.
All shades are radiopaque. Filtek Universal Restorative is offered in
the
following shades: A1, A2, A3, A3.5, A4, B1, B2, D3, XW, and PO. The
pink
opaque shade option can be used to mask discolored or stained tooth
structure, metal discolorations, and amalgam stains.
The fillers are a combination of a non-agglomerated/non-aggregated
20 nm silica filler, a non-agglomerated/non-aggregated 4 to 11 nm
zirconia filler, an aggregated zirconia/silica cluster filler
(comprised
of 20 nm silica and 4 to 11 nm zirconia particles), and a ytterbium
trifluoride filler consisting of agglomerated 100 nm particles. The
inorganic filler loading is about 76.5% by weight (58.4% by volume).
Filtek Universal Restorative contains AUDMA, AFM, diurethane-DMA,
and 1,12-dodecane-DMA. Filtek Universal Restorative is applied to the
tooth following use of a methacrylate-based dental adhesive, such as
manufactured by 3M ESPE, which permanently bonds the restoration to
the tooth structure. Filtek Universal Restorative is packaged in
traditional
syringes and single-dose capsules.
INDICATIONS
• Direct anterior and posterior restorations (including occlusal
surfaces)
• Core build-ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers
PRECAUTIONARY INFORMATION FOR PATIENTS
This product contains substances that may cause an allergic reaction
by
skin contact in certain individuals. Avoid use of this product in
patients
with known acrylate allergies. If prolonged contact with oral soft
tissue