November 16, 2017
AH Plus® root canal sealer and AH Plus Jet® root canal sealer are based on epoxy-amine resin, offering the following features:
● Long-term sealing properties.
● Outstanding dimensional stability.
● Self-adhesive properties.
● Very high radiopacity.
Caution: For dental use only.
In the USA: Rx only
● AH Plus® in tubes fro manual mixing of paste A and paste B.
● AH Plus Jet® mixing syringe offering a more precise, convenient and faster procedure.
● Bisphenol-A epoxy resin
● Bisphenol-F epoxy resin
● Calcium tungstate
● Zirconium oxide
● Iron oxide pigments
● Calcium tungstate
● Zirconium oxide
● Silicone oil
Permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points.
Use with patients who have a history of severe allergic reaction to epoxy resins or amines or any of the other componets.
Be aware of the following general safety notes and the special safety notes in toher chapters of these Instructions for Use.
Safety alert symbol.
● This is the safety alert symbol. It is used to alert you to potential personal injury hazards.
● Obey all safety messages that follow this symbol to avoid possible injury.
The material contains epoxy resins and amines which may be irritating to skin, eyes and oral mucosa and may cause allergic contact dermatitis in susceptible persons.
● Avoid eye contact to prevent irritation and possible corneal damage. In case of contact with eyes rinse immediately with plenty of water and seek medical attention.
● Avoid skin contact to prevent irritation and possible allergic response. In case of contact, reddish rashes may be seen on the skin. If contact with skin occurs, remove material with cotton and alcohol and wash thoroughly with soap and water. In case of skin sensitization of rash, discontinue use and seek medical attention.
● Avoid contact with oral soft tissues/mucosa to prevent inflammation. If accidental contact occurs, remove material from the tissues. Flush mucosa with plenty of water and expectorate/evacuate the water. If inflammation of mucosa persists, seek medical attention.
● Prevent ingestion. If accidental swallowing occurs, have patent drink plenty of water. If nausea or illness develops, seek medical attention.
● Do not place too much sealer to prevent overfilling of the root canal and damage of periapical tissue.
This product is intended to be used only as specifically outlined in these Instructions for Use.
Any use of this product inconsistent with these instructions for Use is at the discretion and sole responsibility of the dental practitioner.
● Use protective measures for the dental team and patients such as glasses and rubbed dam in accordance with local best practice.
● Contact with saliva, blood and sulcus fluid during application may cause failure of the root canal filling. Use adequate isolation such as rubber dam.
● AH Plus Jet® root canal sealer mixing tips are intended for single use only. Do not reuse in order to prevent cross-contamination or malfunction.
If refrigerated, allow material to reach room temperature prior to use.
● Eye contact: Irritation and possible corneal damage.
● Skin contact: Irritation or possible allergic response. Reddish rashes may be seen on the skin.
● Contact with mucous membranes: Inflammation (see Warnings)
Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
● Store at temperature between 10°C and 24°C (50°F and 75°F). Use the product at room temperature.
● Do not use after expiration date.
Step-by-step instructions on how to use AH Plus Endodontic Root Canal Sealer
Prior to the application of the material prepare, clean, and dry the root canals to be filled using state-of-the-art endodontic techniques.
Dosages and mixing
AH Plus Jet® toot canal sealer (tubes)
Appropriate paste condition
Paste B may slightly separate. It has been shown that this process does not negatively affect the performance of the mixed product.
1. Using a metal spaturla¹, mix equal volume units (1:1) of paste A and paste B of AH Plus Jet® root canal sealer on a glass slab or the mixing pad supplied with the package. Mix to a homogenous consistency.
2. Tightly close tubes after use.
3. Do not exchange caps of tubes. The colored cap belongs to the colored tube; the white cap belongs to the white tube.
AH Plus Jet® root canal sealer (mixing syringe)
Appropriate mixing ratios
The syringe filling volumes of pastes A and B vary slightly. To ensure appropriate mixing, bleed the syringe prior the first use.
1. Remove the cap by turning it 90° counter-clockwise and pulling it.
2. Attach the mixing tip² to the syringe, aligning the notch.
3. Turn the tip 90° clockwise and secure the mixing tip in place.
4. Rotate and adjust the tip in angle in order to meet treatment requirements.
5. Use Disposa-Shield® protective barrier³ when cross-contamination can not be avoided.
6. Carefully apply steady pressure onto the plunger. The two pastes are automatically mixed in equal volume units.
7. After having finished remove mixing tip by turning it 90° counter-clockwise and pulling it off (together with protective barrier if any).
8. Replace the cap on the syringe head, aligning the notch, then turn it 90° clockwise.
Damage of periapical tissue.
1. Do not place too much sealer or prevent overfilling of the root canal. For condensation and warm gutta-percha obturation techniques apply only a light coating of sealer onto the canal walls.
2. If overfilling occurs the material is usually tolerated very well by the surrounding tissue. If however material is pressed into the mandibular canal, immediately apply state of care measures.
Condensation and warm gutta-percha techniques
1. As a standard technique, the material is used in combination with gutta-percha or other root canal points.
2. For these filling techniques where most of the canal is obturated by endodontic point material, apply a light coating of sealer with a paper point or file onto the canal walls to the working length and/or apply a light coating of sealer onto the surface(s) of the root canal filling point(s).
3. Insert root canal filling point(s) into the canal according to standard procedure.
1. Select a gutta-percha point (or alternatively a paper point or a reamer) of the size of the last instrument used during apical preparation.
2. Wet the canal walls with the material through a pumping or simultaneously rotating movement in a counter-clockwise direction of the point reamer. Alternatively, apply the material onto the tip of a Lentulo spiral.
3. Advance the Lentulo spiral slowly to the apex running at very slow speed. Avoid the formation of air bubbles in the material and overfilling of the canal.
4. Withdraw Lentulo very slowly still running at low speed.
5. Dip disinfected and dry master point into the material and insert it into the canal with a slow pumping motion.
Working and setting time
● Working time is 4 hours at 23°C (73°F) 4
● Setting time is 24 hours at 37°C (99°F) 5
Removal of root canal filling
If the material is used in combination with (gutta-percha) pints, root canal fillings can best be removed using thermo-mechanical techniques.
1. Disposa-Shield® protective barrier and AH Plus Jet® root canal sealer mixing tips and intended for single use only. Do not reuse in order to prevent cross-contamination of malfunction.
2. Discard in accordance with local regulations.
Clean spatulas, mixing slabs and instruments immediately after use with alcohol or acetone.
Lot number ( LOT) and expiration date
1. Do not use after expiration date. ISO standard is used: “YYYY-MM”
2. The following numbers should be quoted in all correspondence:
● Recorder Number
● Lot number
● Expiration date
1. Mixing ration by weight is 1 g of paste A to 1.18 g of paste B
2. AH Plus Jet® Mixing Tips, ReOrder 606.20.116
3. Disposa-Shield® Infection Control Barrier for low speed, long headpiece, EU ReOrder A880065, US ReIrder/SKU 667006
4. Internal test method.
5. Measured according to ISO 6876:2001 (E). The completely polymerization needs 7 days at 37°C (99°F)