Caution:
U.S. Federal law restricts this device to sale by or on the order of a dentist. For
dental use only.
COMPOSITION AND DESCRIPTION
Regisil
®
2X
™
Bite Registration Material is designed for accurate interocclusal records of bite
registration. Regisil
®
2X
™
Bite Registration Material offers minimum resistance to the patient’s
jaw closure. This minimizes deviation of the mandible and aids in producing consistently
accurate centric relation records. This bite registration material accurately records occlusal
details, enabling the dentist and lab technician to easily seat models with a slight amount of
elasticity. This also aids in accurately seating models and dies by minimizing interferences from
convex tooth surfaces.
COMPOSITION
Polydimethylsiloxane Polymer
Silicon Dioxide Filler
Polymethylhydrogen Siloxane
Plasticizer
Organo Platinum
Pigments
INDICATIONS
1. Regisil
®
2X
™
Bite Registration Material is designed for accurate interocclusal records of bite
registration.
TECHNICAL DATA
Work Time: 30-60 seconds minimum from start of mix at 72°F (22°C)
Minimum Removal Time (MRT): 1 minute 30 seconds
Linear dimensional change: < 0.5%
Maximum strain in compression: 2%
% Recovery from deformation: > 99.5%
% Permanent deformation: < 0.5%
Detail Reproduction: 20m
Shore A Hardness: 70
CONTRAINDICATIONS
None known.
WARNINGS
1. Avoid prolonged or repeated exposure of the Regisil
®
2X
™
Bite Registration Material with skin
and eyes. Irritation and possible corneal damage may result. Skin rash, oral mucosa irritation
and other allergic reactions may occur in susceptible individuals.
Eye and Skin Contact:
Flush eyes with flowing water for 15 minutes and consult a
physician. Flush skin with flowing water for 15 minutes, then wash area with soap and water
after contact. Flush oral tissues with copious amounts of water. Consult a physician if rash
persists.
2. Do not use Regisil
®
2X
™
Bite Registration Material as a temporary reliner. Use of material in
this manner may cause irritation of the oral mucosa.
PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the
Directions For Use.
Any use of this product inconsistent with the
Directions For Use
is at the discretion and sole
responsibility of the practitioner.
2. Do not contaminate Regisil
®
2X
™
Bite Registration Material with latex or “sulfur-containing”
polymeric gloves. Residue from some brands of latex gloves may leach out especially in the
presence of blood, saliva and some astringents and retraction cords. These residues on the
surfaces of teeth can interfere with the chemical set of the poylvinyl surface and lead to loss
of surface detail and inaccuracies. Vinyl or other non-latex gloves are recommended.
3. Use of some hand soaps and lotions can lead to interference with the setting reaction.
4. Regisil
®
2X
™
Bite Registration Material should not be intermixed with or use in conjunction
with conventional polyether, polysulfide, or (condensation cured) silicones.
5. Before use, make certain the material is at room temperature.
6. Elevated temperatures will reduce work time and set times. However, Regisil
®
2X
™
Bite
Registration Material is not affected by minor variations in temperature, pressure or humidity.
7. To obtain optimum physical properties, the mix should be completely homogeneous (streak
free).
8.
Storage and Shelf Life:
Store and use Regisil
®
2X
™
Bite Registration Material between 65°-
80°F (18°-27°C) and in relative humidity of 50% ± 20%. Refer to label on cartridge for
expiration date. Do not use after expiration date. Work time may be affected by temperature.
See Step-by-Step Instructions For Use.
ADVERSE REACTIONS
1. Allergic contact dermatitis, oral mucosa irritation and other allergic reactions may occur in
susceptible individuals.
(See Warnings)
2. Use of this material as a temporary reliner may cause oral mucosa irritation.
(See Warnings)
STEP-BY-STEP INSTRUCTIONS FOR USE
Technique For Cartridge Dispensing Gun Instructions
1. Raise the release lever vertically upward, while simultaneously pulling the plunger all the way
back in the dispenser handle.
2.
Cartridge Loading
2.1 Open cartridge lock by lifting up top clasp.
2.2 Orient and insert cartridge with v-shaped notch facing down.
2.3 Close the top clasp to lock cartridge into dispenser gun.
2.4 Remove the cartridge cap by turning 90° counterclockwise. The cartridge cap can be
replaced on cartridge when storing the cartridge after initial use or the used mixing tip
can be left in place until the next use after disinfection to serve as a self-sealing cap.
2.5 Dispense a small amount of base and catalyst before installing mix tip to ensure even
flow from cartridge. Use gentle pressure. Be sure no plug is present. If any plug blocks
flow, clear with an instrument. Wipe away excess from the cartridge carefully so base
and catalyst do not cross contaminate and cause obstruction of the nozzle.
2.6 Install a mixing tip on the cartridge by lining up the
v-shaped notch on the outside colored rim of the mix tip with the v-shape notch on the
cartridge flange. If mix tip does not seat easily, be sure the internal end view of the mix
tip is aligned correctly. The mix tip itself can turn in its cap. The two holes should line up
with the v-shaped piece that is on the outside rim of the mix tip cap to facilitate
inserting. Turn tip to align in its cap.
2.7 When mix tip colored rim v-notch is lined up with the
v-shaped notch on the cartridge flange, turn colored mix tip cap 90° in a clockwise
direction to lock in place on cartridge.
3.
Dispensing Material
3.1 Squeeze dispenser trigger with moderate and even pressure to begin mixing material.
Material will stop flowing after trigger is released.
3.2 After each use, leave the mixing tip in place until the next use. The mixing tip serves as
self-sealing device.
3.3 For subsequent usage, remove the used mixing tip and squeeze the dispenser trigger to
extrude material from the two openings to cartridge. Wipe end of cartridge. Install a new
mixing tip and twist 1/4 turn clockwise.
4.
Use With or Without Tray
4.1. This material may be used with or without a bite registration tray, but in most
applications, a tray will not be required.
5.
Insertion of Regisil
®
2X
™
Bite Registration Material
5.1 The material may be dispensed directly from the cartridge mixing tip. At 72°F (22°C)
work time is 30-60 seconds and set time is 1 minute 30 seconds from start of mix.
Elevated temperature reduces work and set times.
5.2 The material is then injected directly onto the occlusal surfaces of the patient’s teeth
beginning where the teeth have been prepared. Usually, only mandibular teeth need be
covered, however, in recording the anterior teeth, it is suggested that material be placed
over the teeth of both arches. A layer of about 5 mm of bite registration material is
usually sufficient. In those situations where use of a tray is desired, the mixed material is
placed on both sides of the tray to a depth of 2-3 mm. This material has been found to
work well with mesh fabric type trays.
6.
Removing Regisil
®
2X
™
Bite Registration Material
6.1 After 1 minute 30 seconds from the start of mixing, the material may be removed from
the patients mouth. Have the patient open and carefully release the bite registration
from the teeth. Abrupt force at this stage could cause permanent deformation of the
bite registration.
7.
Cartridge Removal
7.1 To remove the cartridge, hold release lever up and withdraw plunger in a backward
direction.
8.
Model Placement into Registration
8.1 Any excess material extending onto soft tissue areas or below the height of contour of
the teeth should be removed to obtain maximum accuracy when seating the registration
on the model. Excess material extending into inter-proximal areas can interfere with
model placement and should be removed. Best results in trimming are obtained with a
sharp scalpel blade or fine, sharp scissors.
Regisil
®
2X
™
Vinyl Polysiloxane Bite Registration Material
Cartridge System
DIRECTIONS FOR USE – ENGLISH
