premier PIC-Plus Implant Cement Plus User Manual
- October 26, 2023
- Premier
Table of Contents
premier PIC-Plus Implant Cement Plus
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INSTALLATION
Intended Use
Premier® Implant Cement™ / Premier® Implant Cement™ Plus is a non-eugenol temporary cement for luting implant-retained crowns.
Product Description
Premier® Implant Cement™ (PIC)/ Premier® Implant Cement™ Plus (PIC Plus): PIC
and PIC Plus is a dual-barrel catalyst and base system suitable for temporary
cementation of permanent/ definitive implant retained crowns and provisional
restorations where long-term or increased retention is desired. PIC formulated
for temporary cementation of provisional restorations where long-term secure
retention is desired. Product formula designed to offer tight marginal seal
that is resistant to washout and absorb shocks/resist breaking down under
daily occlusal stresses.
Contents:
Premier Implant Cement™/Premier Implant Cement™ Plus is available in various
kit configurations to match the clinical preferences:
Premier Implant Cement (PIC)
| Item No. | Product Configurations |
|---|---|
| I 3001450 | Implant Cement Standard Pack |
– 1 -5ml Automix Syringe
– 10 Mixing tips
– 1-Mixing Pad
3001455| Implant Cement Value Pack
– 3 -5ml Automix Syringe
– 25 Mixing tips
3001451| Package of 25 – Automix Syringe tips
Premier Implant Cement Plus (PIC Plus)
| Item No. | Product Configurations |
|---|---|
| 3001550 | Implant Cement Plus Standard Pack –Shade Pink 1 -5ml Automix Syringe |
10 Mixing tips
3001555| Premier Implant Cement Plus Value Pack – Shade Pink
– 3-5ml Automix Syringe
– 25 Mixing tips
3001551| Implant Cement Plus Standard Pack – Shade White
– 1 -5ml Automix Syringe
– 10 Mixing tips
3001556| Premier Implant Cement Plus Value Pack – Shade White
– 3-5ml Automix Syringe
– 25 Mixing tips
3001451| Package of 25 – Automix Syringe tips
Materials:
Non-Eugenol. Non-fluoride elastomeric resin formula with zirconia glass
fillers
Contraindications:
Do not use Premier Implant Cement™/ Implant Cement™ Plus in cases of:
- Patients with known sensitivity or allergy to resins. Wash exposed area completed removing material. If an allergic reaction is observed, consult a physician immediately and discontinue use with this patient.
- As a temporary cement in contact with fresh restoration made from dual-cure or self-cure core build-up materials or composite resins.
- Eugenol containing temporary cement remains on abutments prior to the use of PIC+PIC Plus.
Precautions:
- Disposable tips are designed for single-patient use only. Do not re-use an mx-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 in order to mitigate potential cross-contamination between patients.
- Avoid contamination of the 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.
- Corrective dental procedures may be necessary if not all excess sub-gingival cement is removed. After cementation, take a radiograph to visualize any sub-gingival residual excess cement, and remove it to prevent future problems.
WARNINGS:
- Do not overfill the crown with the product.
- For use by a trained dental professional only.
- Do not use after the shelf life period indicated on product labeling/packaging.
Adverse Reactions:
Adverse reactions may include but are not limited to:
- Inflammation of soft tissue or bone loss
- Allergic reactions to PIC+PIC Plus 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 PIC+PIC Plus.
PRIOR TO USE:
- Disinfect syringe dispensers using an intermediate level disinfection process (liquid contact) as recommended by the Centers for Disease Control and use a protective plastic sheath barrier on the syringe.
- Ensure a new mix-tip placed on the dispensing end before each for each use.
Chemical Cure Physical Properties
Working time: at last 1.5 minutes at room temperature
Gel phase: 2-2.50 minutes at 98.6°F/37°C
Final set: 4 to 5 minutes at 98.6°F/37°C
DIRECTIONS FOR USE (Please follow carefully)
- Check fit, occlusion and proximal contacts of the restoration. Complete all finishing procedures.
- Dry and isolate the prepared abutments. Absolute dryness is not necessary, but obvious contamination should be avoided.
- Bleed the syringe before installation of the automix dispensing tip. Mount a new automix dispensing tip onto the PIC+PIC Plus dual-barrel syringe and bleed the syringe again. This assures equal flow ratio of base and catalyst components.
- For firm retention, only a thin layer of PIC+PIC Plus should be applied to the cervical third of the crown (or up to the cervical half depending on the amount of retention desired). Dispense a small bead of PIC+PIC Plus onto a microbrush. Use the microbrush to place a thin film of cement along the inside wall of the cervical third of the restoration, making sure to completely coat the margin with cement. Discard excess cement. You have at least 1.5 minutes of working time at room temperature.
- Note: Excess cement should be avoided. Applying too much cement can cause future retrieval of the restoration to become difficult or impossible.
- Firmly seat the crown and either hold in place or have the patient close on a cotton roll until the initial set, which occurs in 2-2.5minutes. The initial set is characterized by a distinct gel phase. Safely remove the excess cement without scratching the implant or abutment after 2.5minutes, but before final set. Note: Safe removal of excess cement achieved by using an implant friendly instrument such as Premier® Implant Scalar.
- Final cement set is between 4-5 minutes, depending on operating environmental conditions.
Storage:
- PIC+PIC Plus can be stored in a temperature range 4°C(39°F) – 24°C(75°F).
- Do not store at a temperature over 24°C (75°F). Do not freeze.
- Allow material to warm to room temperature prior to use.
Shelf Life:
- PIC+PIC Plus has a shelf life of 2 years (24 months) from the date of manufacturing.
- Do not use after product has expired. See expiry date on the product label.
For Further Information:
To obtain an SDS or IFU, visit
www.premierdentalco.com or call Premier at
610-239-6000.
Symbol Key
Symbols Symbol Meaning
- Expiry date
- Manufacturer
- Batch number
- Caution: See instructions for use
- The upper and lower limits of the temperature of use, storage and transportation
- Irritant (Skin and Eye) Skin Sensitizer. Acute Toxicity
- “CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician
- See IFU on www.premierdentalco.com
Manufacturer:
Premier® Dental Products Company (PDPC)
1710 Romano Drive
Plymouth Meeting, PA 19462 U.S.A.
(610) 239-6000 • premierdentalco.com
Made in Israel.
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany