parkell 21-M144 Retrieve DC Implant Cement Kit Instruction Manual

parkell 21-M144 Retrieve DC Implant Cement Kit Instruction Manual

►STORE TIGHTLY SEALED IN A COOL, DARK, LOW HUMIDITY ENVIRONMENT. REFRIGERATION IS ACCEPTABLE, BUT DO NOT FREEZE. BRING PRODUCT TO ROOM TEMPERATURE BEFORE USE.

► PRODUCT DESCRIPTION

Parkell’s Retrieve®-DC is a resin-based, dual-cured dental cement designed to permit long-term provisional cementation of implant-supported prostheses. It will adhere to dental implants composed of metal alloys or ceramics without priming, contains no eugenol and has radiopacity comparable to the best permanent cements (~270% of Aluminum). Because the cement’s final set is slightly flexible retrieval from the mouth is possible when restorations are placed on appropriately lubricated abutments.
The Retrieve-DC Long-term Provisional Implant Cement Kit ( h S251) includes:

• (1) Dual-chamber 1:1 cartridge (5 ml) of Retrieve-DC
• (1) Hand plunger for cartridge dispensing
• (10) Mixing tips (brown-base, pointed, 1:1 mixing ratio). Note: A refill bag of 30 mixing tips is available from Parkell ( h S292).
• Instructions for Use

► INDICATIONS FOR USE

Parkell’s Retrieve®-DC is a resin-based, dual-cured, two-component dental cement. It is intended for mind- to long term (semi-permanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the protheses, if necessary. Retrieve can also be used as a temporary filling material.

► CONTRAINDICATIONS AND PRECAUTIONS

• Parkell’s Retrieve-DC is not for internal consumption, other than as a cured dental restorative material. The cartridge should be kept away from children.
• This product is CONTRAINDICATED for use on or by persons who are sensitive to acrylates, methacrylate’s or similar materials. Contact between uncured resins and oral mucosa may cause temporary irritation. Symptoms may include dermatitis or inflammatory reactions. If this occurs, discontinue use, wash with copious amounts of water and obtain medical care if necessary.
• If product accidentally contacts eyes, flush with water and obtain medical care immediately.
• The material is flammable. AVOID OPEN FLAME, and use in well-ventilated areas.
• 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 contact with fresh eugenol-containing products.
• Working & setting times will vary based on temperature, humidity, product age and storage conditions.
• Avoid sunlight or nearby heat sources. Shelf life will be reduced if not stored properly.

► IMPORTANT CLINICAL GUIDELINES

• To facilitate future removal of a prosthesis cemented to an implant abutment (with or without a coating of bonding agent) when using Retrieve-DC, it is imperative that the abutment be lubricated with a water-based gel lubricant or glycerine. Prior to cementation, coat at least 50% of the coronal portion of the implant abutment head with lubricant, but avoid lubricating the restoration margin. This should give good retention, while allowing removal of the prosthesis later.
• If this product sets in intra-oral undercuts, it may lock on, making prosthesis removal extremely difficult. Avoid using in extreme undercut situations.
• If the abutment is air-abraded prior to cementation, removal may be difficult. Exercise professional judgment when roughening the bonding surfaces prior to cementation.
• To avoid marginal leakage or discoloration, disinfect the abutment prior to cementation.
• Immediately after cementation using Retrieve-DC, take a radiograph to visualize any sub-gingival residual excess cement, and remove it to prevent future problems.
• This product is designed and tested for use on dental alloys and ceramics only. For temporary cementation of prostheses on natural teeth, consider Parkell’s E.T.C.TM Temporary Resin Cement ( h S255).

► SELF-CURE PRODUCT TIMING:

• Working Time (at 72° F / 22° C): 1:30- 2:30 minutes
• Setting Time (at 98.6° F / 37° C): 4:00- 6:00 minutes

NOTE: Times will vary based on temperature, humidity, product age and storage conditions.

► LIGHT-CURE PRODUCT TIMING:

At an activation wavelength of 430-480nm and an intensity of >600 mW/cm2, follow these guidelines:

• Halogen Light: 10 sec.
• Light Emitting Diode (LED) Light: 10 sec.
• High Intensity LED Light: 5 sec.
• Plasma Arc Curing (PAC) Light or Laser: 3 sec.

► SURFACE PREPARATION AND ROUGHENING PRIOR TO BONDING

1. Surfaces being bonded together must be free of plaque, debris, greases, oils and other contaminants prior to bonding. Appropriate dental solvents like Parkell’s Cavidry™ ( h S099) work well to accomplish this, followed by a water rinse and air drying.
2. Inner surface of prosthesis may be roughened prior to bonding to maximize bond strength. Dental “sandblasters” do an excellent job at roughening many ceramics, plastics and metals, much better than rotary abrasives. For certain other ceramics or metals, appropriate etching acids may be recommended. Consult specific material manufacturer for details.
3. Outer surface of abutment should NOT be roughened prior to bonding, as this will interfere with future removal of prosthesis.

► GENERAL INSTRUCTIONS FOR MIXING

1. Separate priming of the surface is not necessary.

2. To facilitate future removal and preclude “locking on” of a Retrieve-DC-cemented prosthesis to an implant abutment, water-based gel lubricants such as KY® Jelly or glycerine must be applied to most of the coronal portion of the abutment head prior to cementation.

3. Before first use, remove and discard the brown sealing cap. Express out a small amount of Retrieve-DC through both round orifices onto a mixing pad, and wipe the orifices with a tissue.

4. Attach a brown-base, 1:1 mixing tip ( h S292) onto the cartridge and twist ¼ turn to lock. Express a small amount of mixed Retrieve-DC onto a mixing pad to confirm good flow and mixture.

5. Immediately express a small amount of cement into the clean and dry intaglio of the prosthesis. Use a plastic instrument to spread a thin layer of the cement over the entire inner surface of the crown. Overfilling the crown may make seating difficult. Alternatively, a bead around the marginal area works well, as it seals the margins without interfering with seating or creating excessive retention.

6. Seat the prosthesis onto the implant abutment(s) and:
   • Allow the excess cement to self-cure until gelled, or
   • Expose the excess cement to a dental curing light for 3-5 seconds, to allow it to gel.

7. Remove the gelled excess cement with the appropriate dental instrument.

8. Immobilize the prosthesis until setting is evident, either by self-curing or light-curing. Retrieve-DC will fully self-cure in about 5 minutes, depending on oral temperature.

9. Take an immediate radiograph to visualize any sub-gingival residual excess cement. This product’s excellent radiopacity makes it easy to see. Remove all excess cement with appropriate instruments to prevent future gingival problems or cement-induced peri-implantitis.

10. Leave the used mixing tip in place on the cartridge to serve as the sealing cap between uses.

11. The cartridge and used mixing tip may be disinfected with appropriate dental surface disinfectants, as described below. Check with the disinfectant manufacturer before use.

12. Retrieve-DC may also be hand-mixed by removing the sealing cap from dual-barrel syringe and dispensing equal amounts of base and catalyst onto a paper mixing pad. Spatulate until they are fully incorporated. Re-seal the cartridge with the original cap, taking care to align the V on the cap with the notch on the cartridge collar. This will assure that the proper plugs fit the holes. If the plugs are reversed, the cement may set prematurely in the syringe.

► INSTRUCTIONS FOR CEMENT REMOVAL PRIOR TO RECEMENTATION:

1. Carefully remove cemented crowns from implants utilizing your preferred technique (eg. a hooked hand instrument, a crown-removal device or crown-removing pliers).
   • If future removal of a metal crown or PFM is anticipated, leave a small, rounded, lingual metal shelf or “pin” in place after insertion. This will allow a crown remover to get a good grip without damaging the porcelain. Rounding the metal will make it undetectable to the patient’s tongue.
   • To avoid fracture, use extreme caution when attempting the removal of any all-ceramic crown.

2. Inspect the exterior of the abutment and the interior of the prosthesis for a clear or white film layer. A solvent like acetone will soften this layer if needed, and make it easier to remove from the surface with a hand scaler or curette, or an ultrasonic scaler tip.

3. Wash the crown with water and air-dry to assure that the surface is clean prior to refermentation.

► DISINFECTION OF CONTAINERS

Cartridges and caps should be cleaned of debris with a water-damp paper towel and disinfected with a paper towel saturated with an EPA-registered low-level (HIV/HBV claim) to intermediate-level (tuberculocidal claim) hospital disinfectant. Afterwards, the chemical residue should be wiped off with a water-damp paper towel and air-dried. Utilize the surface disinfecting protocol of the disinfectant manufacturer. Consult www.CDC.gov for the most recent version of the “Guidelines for Infection Control in Dental Health-Care Settings”.
Tips for Dental Practitioners: the following information should help dental practitioners reduce the risk of cross-contamination between patients when using multiple-use dental dispensers: apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient; use new, uncontaminated gloves when handling multiple-use dental dispensers; utilize dental assistants to dispense material for the dentist; avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth; do not reuse the multiple-use dental dispenser if it becomes contaminated; do not reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants; do not immerse multiple-use dental dispensers in a high level chemical disinfectant, as this may damage the dispenser and the material contained in the device; do not sterilize multiple- use dental dispensers, as this may damage the material contained in the device.

► WARRANTY AND TERMS OF USE:

For full Warranty and Terms of Use information, please see www.parkell.com. Safety Data Sheets (SDS) are available at www.parkell.com. Parkell’s Quality System is certified to ISO 13485.

►EXPLANATION OF SYMBOLS USED

www.parkell.com

References

• Dental Tools, Devices and Materials
• Dental Instruments, Devices and Materials

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