premier ZR-Cem Self Adhesive Universal Resin Cement Instruction Manual

: June 13, 2024
: Premier

Table of Contents

premier ZR-Cem Self Adhesive Universal Resin Cement
Product Information
Product Usage Instructions
Product Description
References
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premier ZR-Cem Self Adhesive Universal Resin Cement

premier-ZR-Cem-Self-Adhesive-Universal-Resin-Cement-
PRODUCT

Product Information

Name: Self-Adhesive Universal Resin Cement

Intended Use: ZR-Cem is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts, and veneers. It is also used for cementation of crown restorations to implants.

Product Description: ZR-Cem is a self-etch, dual cure, adhesive resin cement that is specially formulated for zirconia cementation; however, it is also indicated for definitive cementation of all ceramic, composite and metal restorations.

Restorative Substrates: ZR-Cem can be used with the following restorative substrates:

Ceramic Materials
CAD/CAM milled
Metal-based

Contents: Premier ZR-Cem is available in various kit configurations:

SKU	Description
3001560	Shade White
4001561	Shade A2
3001562	Shade Translucent
3001418	N/A

Materials: Non-Eugenol. Non-fluoride adhesive resin formula.

Warnings: Do not use if there is a sensitivity or severe allergic reaction to methacrylate resins or any of the components. Serious incidents should be reported to the manufacturer and/or competent authority.

Dual-Cure Physical Properties:

Light-cure setting times: 20 seconds with light intensities of ≥ 500 mW/cm2, 30 seconds with light intensities of < 500 mW/cm2

Product Usage Instructions

Prepare Restoration
Verify that the laboratory has pre-treated the final restoration in accordance with the manufacturer’s instructions.
Clean intaglio surface of restoration with alcohol (or per restoration manufacturer’s instructions), then dry well with oil-free air.
Apply ZR-Cem Cement
Select desired shade of ZR-Cem cement.
Bleed cartridge before initial use and place mixing tip on Auto-Mix syringe.
Mount the supplied intra oral tip onto the mixing tip. Bleed again through the tips.
Dispense the cement:

  * Inlay/Onlay: Dispense the cement directly into the cavity preparation covering all surfaces.
  * Crown/Bridge: Dispense the cement directly into the gingival 3rd of the restoration.
  * Post: Prepare post space in the canal. Dispense cement into the post space while keeping tip immersed in the cement to prevent air entrapment. Fill the post space with ZR-Cem.

Seat Restoration
Inlay/Onlay: Seat the restoration gently onto the preparation allowing the cement to flow from all sides.
Crown/Bridge: Seat the restoration gently onto the preparation allowing the cement to flow from all margins.
Post: Seat post into post space allowing excess cement to vent from canal space. Stabilize the post by light curing coronal portion of the post for 2-3 seconds.
Clean up Marginal Excess
After the restoration is properly seated, remove all excess cement. Excess cement is best removed in its gel state with a scaler or explorer.
Self-Cure: Under light curing, excess cement will reach the gelled state in a few seconds.
Light Cure: Remove excess cement. Note: Cement within the crown or canal has not yet set. Do not move or disturb the crown or post during cleanup.

Intended Use
ZR-Cem is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts, and veneers. It is also used for cementation of crown restorations to implants.

Product Description

ZR-Cem is a self-etch, dual cure, adhesive resin cement that is specially formulated for zirconia cementation; however, it is also indicated for definitive cementation of all ceramic, composite and metal restorations.

Examples of Restorative Substrates to be used with ZR-Cem

Ceramic Materials

| • Zirconia (low and high translucency)

• Alumina

• Lithium Disilicate

• Zirconia-reinforced Lithium Silicate

• Feldspathic and Leucite-reinforced

• Ceramics

CAD/CAM milled| • Composites

• Ceramics

Metal- based| • Crown and Bridge Alloys

• PFMs

Contents:
Premier ZR-Cem is available in various kit configurations to match the clinical preferences:

SKU	Description

3001560

Shade White

4001561

Shade A2

3001562

Shade Translucent

| ZR-Cem Standard Pack

• 1 – 8g Syringe

• 10 – Mix-tips

• 10 – Intraoral tips

3001418| ZR-Cem Refill Tips

• 35 – Mix-tips

• 35 – Intraoral tips

Materials:
Non-Eugenol. Non-fluoride adhesive resin formula.
Contraindications:

Do not use on patients who have a history of known sensitivity or severe allergic reaction to methacrylate resins or any of the components.
PRECAUTIONS:
Disposable tips are designed for single patient use only. Do not re-use a mix-tip.
Working & setting times will vary based on temperature, humidity, and product age and storage conditions.
Use a protective plastic sheath barrier on the syringe to mitigate potential cross-contamination between patients.
Avoid contamination of product. Do not mix components with those of other materials. Do not return dispensed components to their original container. Dispose of leftover material properly.
Avoid sunlight or nearby heat sources. Shelf life will be reduced if not stored properly.
Avoid contact with skin, eyes, and soft tissue. Wash thoroughly with water after contact.
Prescription device, Rx only.
WARNINGS:
For use by a trained dental professional only.
Do not use after the shelf-life period indicated on product labeling/packaging.
Large amounts of excess material may generate heat as part of the normal setting reaction.
Adverse Reactions:
Adverse reactions may include but are not limited to:
Inflammation, irritation, or damage of soft and hard tissue.
Allergic reactions to ZR-Cem material. Wash exposed area completed to remove material. If an allergic reaction is observed, consult a physician immediately and discontinue use with this patient.
Pain, discomfort, and/or abnormal sensations due to the presence of ZR-Cem.
Uncured methacrylate resin may cause contact dermatitis and damage the pulp.

If a serious incident has occurred in relation to the device, please report the incident to the Manufacturer and/or competent authority of the Member State where the device was used.

Dual-Cure Physical Properties:

Chemical-cure
72°F (22°C) temperature
Working time: 1.5 – 2.5 minutes.
Higher temperatures accelerate set.
98.6° F (37° C) temperature
Gel phase: approximately 1-1.5 minutes
Final set: 3.0 – 4.0 minutes.
Higher temperatures accelerate set.
Light-cure setting times:
20 seconds with light intensities of = or > 500 mW/cm2
30 seconds with light intensities of < 500 mW/cm2

Directions for use: (Please follow carefully)

Pretreatment of Tooth
Remove the provisional restoration and all temporary cement residue. Note: Use only temporary cements that are eugenol-free. The use of eugenol-containing temporary luting materials can inhibit the polymerization process of ZR-Cem.
Mechanically clean prepared tooth (e.g. with pumice paste).
Rinse preparation thoroughly and air dry. Do not desiccate – over drying can lead to post-operative sensitivity.

  * Note: Tooth preparation should leave the tooth surface evenly moist. Dry preparation (air-dried or alcohol dried), and wet preparations (with pooled surface water), can reduce adhesion.
  * Note: The adjacent teeth and/or the external surfaces of the restoration may be lubricated with a water soluble medium to ease cleanup of excess cement.
4. Try in the restoration to ensure proper fit.

Prepare Restoration
Verify that the laboratory has pre-treated the final restoration in accordance with the manufacturer’s instructions.
Clean intaglio surface of restoration with alcohol (or per restoration manufacturer’s instructions), then dry well with oil-free air.
Apply ZR-Cem Cement
Select desired shade of ZR-Cem cement.
Bleed cartridge before initial use and place mixing tip on Auto-Mix syringe.
Mount the supplied intra oral tip onto the mixing tip. Bleed again through the tips.
Dispense the cement:
Inlay/Onlay| Dispense the cement directly into the cavity preparation covering all surfaces.
---|---
Crown/Bridge| Dispense the cement directly into the gingival 3rd of the restoration
Post| Prepare post space in the canal. Dispense cement into the post space while keeping tip immersed in the cement to prevent air entrapment. Fill the post space with ZR-Cem.
Seat restoration
Inlay/Onlay| Seat the restoration gently onto the preparation allowing the cement to flow from all sides.
---|---
Crown/Bridge| Seat the restoration gently onto the preparation allowing the cement to flow from all margins.
Post| Seat post into post space allowing excess cement to vent from canal space. Stabilize the post by light- curing coronal portion of the post for 2-3 seconds.
Clean up Marginal Excess
After the restoration is properly seated, remove all excess cement. Excess cement is best removed in its gel state with a scaler or explorer.
5.1.a

Self- Cure

| Excess cement will reach the gelled state in

approximately 1 – 1.5 min after application.

• Allow cement to self- cure for 1 – 1.5 min, then remove the excess cement.

---|---
5.1.b

Light Cure

| Under light curing, excess cement will reach the gelled state in a few seconds.

• Within the first minute following intraoral insertion light-cure excess cement at the margin by moving light tip around the buccal and lingual margin for 2-3 seconds.

2. Remove excess cement. Note: Cement within the crown or canal has not yet set. Do not move or disturb the crown or post during cleanup.

Final Cure
For high-translucency zirconia and other light transmittable restorations (material thickness ≤ 2.5mm), light cure all surfaces including margins for 20 seconds.
For non-light transmittable restorations or light transmissible restorations with material thickness > 2.5mm, allow ZR-Cem to self-cure for 4 minutes from start of mix.
Finish and polish as needed. Use finishing strips for proximal areas. Polish margins with polishing discs, cups, or points.
Check occlusion.

Note: Premier Universal Primer can be used to help achieve maximum bond strength for cases that require additional retention (e.g., short and/or over- tapered preparations).

Storage: