EndoREZ®
EndoREZ®
EndoREZ®
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EndoREZ ®<br />
UDMA Resin<br />
Root Canal Sealer<br />
Description:<br />
A unique biocompatible<br />
methacrylate-based root canal sealer/filler. EndoREZ ® is a two part, mixed, chemical<br />
set material. EndoREZ has hydrophilic characteristics providing excellent penetration<br />
into dentinal tubules. This allows for improved sealing properties combined with ease<br />
of placement and removal. Radiopacity equivalent to gutta percha simplifies<br />
radiographic interpretation. EndoREZ does not compromise dentin bonding agents or<br />
luting resin polymerization.<br />
Indications:<br />
EndoREZ is designed to be used with gutta percha for the filling of cleaned and<br />
shaped root canals. The tiny 30 gauge NaviTip in conjunction with one master cone<br />
provides optimum sealing. EndoREZ can be used with conventional endodontic<br />
obturation techniques and/or hot gutta percha.<br />
Procedure:<br />
Note: Prior to obturation, canals have been instrumented then cleaned and disinfected using significant quantities of sodium<br />
hypochlorite solution (ChlorCid ® ). We recommend the new Endo-Eze ® Anatomic Endodontic Technique instrumentation system in<br />
conjunction with sodium hypochlorite solution delivered through the unique NaviTip.<br />
Be sure all sodium hypochlorite solution or other antimicrobial irrigants are flushed from canal with clean water.<br />
Removal of all excess fluids is simplified with a capillary tip attached to the high velocity vacuum system followed by paper<br />
points.<br />
Note: If clean (bacteria free) water is not available to thoroughly rinse antimicrobial agent (sodium hypochlorite) before placing<br />
EndoREZ, three proven alternatives may be used, EDTA solution, local anesthetic solution, or chlorhexidine solution (e.g.<br />
Consepsis ® ). We recommend EDTA solution as last irrigant wash to maximize seal potential.<br />
Suggested mixing and delivery:<br />
1. Instrument canal. Clean and disinfect canal with antimicrobial agent (sodium hypochlorite). Thoroughly rinse<br />
antimicrobial solution from canal with clean bacteria free water before placing EndoREZ. If clean bacteria free water<br />
is not available use EDTA solution, local anesthetic solution or chlorhexidine solution (Consepsis ® ) to thoroughly rinse<br />
canal.<br />
Important Note: Use peroxide free lubricants or irrigants as oxygen generated from peroxide can inhibit the set of<br />
resins, including EndoREZ. File-Eze ® is a peroxide-free, EDTA endodontic file lubricant. It may be used throughout<br />
the procedure with sodium hypochlorite irrigation. Carefully read all manufacturers instructions. Do not use any<br />
lubricant or irrigant not specifically designed for endodontic use.<br />
2. Trial fit master cone to desired length for all canals being filled. Verify fit radiographically if necessary. Remove cone.<br />
1 Louw NP, Histopathological Evaluation of Root Canal Sealer in Subhuman Primates. (IADR Abstract #1019) J Dent Res 2001; 80:654 (Lit #2)<br />
2 Becce C, SEM Study of a New Endodontic Root Canal Sealer. (AADR Abstract #866) J Dent Res 2001; 80:144 (Lit #16)<br />
3 Becce C, Biocompatibility of a New Endodotic Sealer. (IADR Abstract June 2003)<br />
4 R.B. Kazemi, Sealing Properties of a New Injectable Root Canal Filling Material. (IADR Abstract June 2003)
3. Remove cap from TwoSpense ® 2 syringe. Express a small amount on pad to verify uniform flow of base and catalyst (Fig. 1).<br />
Confirm the presence of the mixer inside the Ultra-Mixer mixing tip. Attach Ultra-Mixer tip to the TwoSpense 2 syringe.<br />
Express a few millimeters of “mixed” material onto mixing pad before filling into the Skini syringe to assure that mixed<br />
material is flowing.<br />
4. Attach appropriate length NaviTip to Skini syringe. Ensure tip is firmly attached to prevent tip loss during sealer/filler<br />
placement.<br />
5. Insert Ultra-Mixer tip into back end of Skini syringe. Dispense desired quantity of material in back end or front end of syringe<br />
(Fig. 2). Insert plunger and press down until air is out of syringe and material is flowing from NaviTip. Express a small amount<br />
on pad. Note quantity that flows from NaviTip in a few seconds, this gives an idea of how long it takes to fill the canal.<br />
Important note: Make sure canal has been cleaned and shaped before inserting NaviTip with EndoREZ into canal. This is<br />
necessary for quality root canal treatment, but it is also important to prevent dentin debris etc. from jamming with EndoREZ<br />
into tip end and preventing flow from tip.<br />
6. Insert NaviTip into canal to within 2-3mm of apex or short of snug fit within canal (Fig. 3). Do not deliver into<br />
canal if a tight fit is noted. Doing so may express excessive EndoREZ beyond apex (see precaution #5). If you don’t<br />
see EndoREZ flowing up canal around NaviTip, stop delivering and ensure tip is not clogged or ensure material is not<br />
being expressed past the apex. Do not use force to push EndoREZ plunger to express material as you might push<br />
material past apex. Do not use plastic tips or Capillary tips to deliver EndoREZ into canal.<br />
7. Withdraw Skini syringe slowly while delivering sealer into canal space. Filling canal space to pulpal floor will provide<br />
adequate sealer to obturate canal.<br />
8. Insert pre-fit master cone into place. Avoid multiple placements and pumping action to minimize risk of expressing<br />
EndoREZ beyond apex (see precaution #5). Note: For large canals insert extra gutta percha cones to minimize large<br />
masses of EndoREZ; simply “harpoon” in as lateral condensation is not necessary.<br />
9. Trim excess gutta percha at canal orifice with hot instrument. EndoREZ will begin to set in 7 to 8 minutes, and will be firm<br />
set in canal in 15 to 20 minutes (body temperature).<br />
10. Mixing tip should be left onTwoSpense 2 syringe between patients.<br />
11. It is normal for EndoREZ to not completely set in the one to three millimeters immediately adjacent to provisional filling<br />
materials. It has long been known that eugenol and eugenol-like chemistries inhibit the set of most all dental resins (one to<br />
three millimeters deep potentially). To facilitate immediate definitive bonded restoration placement and to minimize or prevent<br />
surface inhibition under provisionals, a small quanitiy of Ultra-Blend ® plus or a flowable composite can be delivered via a<br />
Black Micro ® tip to the just placed EnodREZ at the canal orifice and light cured.<br />
Pad mixing and syringe delivery:<br />
To mix EndoREZ, remove cap from the TwoSpense 2 syringe and express material directly onto mixing pad and mix with spatula<br />
as usual. Backload material into small skini syringe with spatula. Deliver mixed EndoREZ to canals with NaviTip attached per<br />
steps 5 thru 7 above. Place gutta percha, etc. as per steps 8 onward.<br />
Note: As with other resins, oxygen inhibition will greatly affect or prevent setting of mixed EndoREZ on the open mixing pad.<br />
Posts:<br />
Begin post preparation with number 2-4 Gates Glidden Drill first, followed by post preparation drills of choice. EndoREZ is easily<br />
drilled out for placement of posts. We recommend microabraded titanium or bondable resin/fiber PermaPosts cemented with<br />
PermaFlo ® DC dentin adhesive and dual cure resin luting system.
Suggested Mixing Technique:<br />
Fig. 1 Express equal amounts<br />
of base and catalyst onto pad to<br />
ensure evenness of flow.<br />
Fig. 2 Place mixing tip in Skini<br />
syringe. Dispense desired quantity<br />
of material in back end of syringe.<br />
Insert plunger and press down<br />
until air is out of syringe and<br />
material is at front end.<br />
Fig. 3 Place NaviTip within 2-<br />
3mm of apex. Dispense EndoREZ<br />
while withdrawing the NaviTip<br />
from the canal. Don’t deliver with<br />
plastic tips.<br />
Precautions:<br />
1. Do not use peroxide containing irrigants or lubricants as oxygen generated from peroxide can inhibit the set of resins<br />
including EndoREZ.<br />
2. For offices which do not have bacteria free water, thoroughly rinse antimicrobial solution (sodium hypochlorite) from canal<br />
before placing EndoREZ. Three proven alternatives are: EDTA solution, local anesthetic solution, or chlorhexidine solution<br />
(Consepsis). Dry canal and deliver EndoREZ as per instructions above.<br />
3. Do not use Iodoform Gutta Percha with EndoREZ as it inhibits the set around the cone.<br />
4. Do not use any lubricant or irrigant not specifically designed for endodontic use.<br />
5. Do not use on patients with known sensitivity to resins including methacrylates.<br />
6. Always make sure NaviTip is at least 2-3mm short of apex and always at least loose in the canal, even if this requires pulling the<br />
tip further out of the canal before delivering the EndoREZ. Do not express material past apex. Do not “pump” material past the<br />
apex during gutta percha placement. Small amounts seen radiographically are not problematic.<br />
7. Do not deliver EndoREZ with tips which could easily occlude the canal, such as plastic Capillary or MicroCapillary tips.<br />
Always express a small quantity of material on a pad to develop an understanding of plunger travel to volume<br />
expressed. Don’t deliver illogical volumes into the canal, if material isn’t seen coming up the canal around the NaviTip<br />
either the tip is clogged or the material is being expressed into anatomic spaces beyond the apex.<br />
8. Do not use force to push EndoREZ plunger to express material.<br />
9. Tips are disposable.<br />
10. The TwoSpense 2 delivery system is not intended for intraoral use.<br />
11. Wipe TwoSpense 2 openings before recapping. Be sure to avoid cross-contamination when wiping syringe.<br />
12. EndoREZ is designed not to set hard like standard resin composites when polymerized. It can readily be drilled out for post<br />
placement or to facilitate retreatment. It may never set on mixing pad etc. where it is exposed to air. To confirm set, check what<br />
has been left in sealed Skini syringe. Note: It is normal for EndoREZ to not set in the one to three millimeters immediately adjacent<br />
to provisional filling materials. It has long been known that eugenol and eugenol-like chemistries inhibit the set of most dental<br />
resins (one to three millimeters deep). To facilitate immediate, definitive bonded restoration placement, or to prevent surface<br />
inhibition under provisionals, a small amount of Ultra-Blend ® plus or flowable composite can be delivered to the just placed<br />
EndoREZ at the canal orifice and light cured. Inhibited resin in the top of canal does not pose a practical problem.<br />
13. Carefully read and understand all instructions before using product.
EN-Key:<br />
DE-Legende:<br />
FR-Explication:<br />
°F °C<br />
46 46° 8°<br />
36 36° 2°<br />
NL-Erklärung der Packungssymbole:<br />
IT-Legenda:<br />
ES-Clave:<br />
EN-Irritant<br />
DE-Irritierend<br />
FR-Irritant<br />
NL-Irriterend<br />
IT-Irritante<br />
ES-Irritante<br />
PT-Irritante<br />
SV-Irriterande<br />
DA-Lokalirriterende<br />
FI-Ärsyttävä<br />
EL-Ερεθιστικ<br />
EN-Recommended storage temperature.<br />
DE-Empfohlene Lager-Temperatur.<br />
FR-Température de Stockage Recommandée.<br />
NL-Aanbevolen bewaartemperatuur.<br />
IT-Temperatura di stoccaggio consigliata.<br />
ES-Temperatura recomendada para almacenamiento.<br />
PT-Temperatura de armazenagem aconselhada.<br />
SV-Rekommenderad Förvaringstemperatur.<br />
DA-Anbefalet Opbevaringstemperatur.<br />
FI-Suositeltu säilytyslämpötila.<br />
EL-Συνιστώµενη θερµκρασία απθήκευσης<br />
PT-Legenda:<br />
SV-Teckenförklaring:<br />
DA-Tegnforklaring:<br />
EN-Keep out of reach of children.<br />
DE-Außerhalb der Reichweite von Kindern aufbewahren.<br />
FR-Tenir hors de portée des enfants.<br />
NL-Buiten bereik van kinderen houden.<br />
IT-Tenere fuori dalla portata dei bambini.<br />
ES-Manténgase fuera del alcance de los niños.<br />
PT-Manter fora do alcance das crianças.<br />
SV-Förvaras utom räckhåll för barn.<br />
DA-Opbevares utilgængelig for børn.<br />
FI-Pidettävä poissa lasten ulottuvilta.<br />
EL-Φυλάτε µακριά τα παιδιά.<br />
FI-Merkkien selitykset:<br />
EL-Kλειδί:<br />
EN-Dentist Dispensed.<br />
DE-Vom Zahnarzt abzugeben.<br />
FR-Distribué par le chirurgien dentiste.<br />
NL-Door de tandarts verstrekt.<br />
IT-Prescritto dal dentista.<br />
ES-Administrado por el Dentista.<br />
PT-Administrado pelo dentista.<br />
SV-Appliceras av tandläkare.<br />
DA-Administreret af tandlæge.<br />
FI-Hammaslääkärin käyttöön.<br />
EL-∆ιανέµεται απ τν δντίατρ.<br />
EN-Destroy after use.<br />
DE-Nach Gebrauch vernichten.<br />
FR-Détruire après utilisation.<br />
NL-Na gebruik vernietigen.<br />
IT-Distruggere dopo l’uso.<br />
ES-Destrúyalo después de usarlo.<br />
PT-Destruir após usar.<br />
SV-Förstöres efter användning.<br />
DA-Destruér efter brug.<br />
FI-Hävitä käytön jälkeen.<br />
EL-Καταστρέψτε τ µετά τη ρήση.<br />
EN-Not for injection.<br />
DE-Nicht zur Injektion.<br />
FR-Ne pas injecter.<br />
NL-Niet injecteren.<br />
IT-Non per iniezione.<br />
ES-No debe inyectarse.<br />
PT-Não injectar.<br />
SV-Ej för injektion.<br />
DA-Ikke til injektion.<br />
FI-Ei injektiokäyttöön.<br />
EL-Μη ενέσιµ.
Ultradent syringes have an expiration date stamped on the side of the syringe consisting of one letter and three numbers.<br />
The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date.<br />
The first two numbers are the month, and the third number is the last number of the year.<br />
Health<br />
EndoREZ<br />
Flammability<br />
0<br />
1<br />
0<br />
MSDS Included.<br />
Reactivity<br />
Hazard Rating<br />
4 = Severe<br />
3 = Serious<br />
2 = Moderate<br />
1 = Slight<br />
0 = Minimal<br />
Shelf life: 24 months. Refrigeration Required.<br />
U.S. federal law restricts this device to sale by or on the order of a dentist.<br />
Keep out of reach of children.<br />
For immediate reorder and/or complete descriptions of Ultradent’s product line,<br />
refer to Ultradent’s catalog or call Toll Free 1-800-552-5512.<br />
Outside U.S. call (801) 572-4200,<br />
or visit www.ultradent.com.<br />
© Copyright 2003 Ultradent Products, Inc. All Rights Reserved.<br />
U.S. Patent Nos.: 5,290,259; and 6,500,004. U.S. Patents Pending.<br />
Manufactured by: Ultradent Products, Inc.<br />
505 West 10200 South, South Jordan, Utah 84095, USA #11584.11 121703