parkell MucoHard+ Hard Denture Reline Kit Instructions

Denture Reline Material
Instructions for Use
hS640, S641, S642

| Store at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store near excessive heat, light, or fresh eugenol-containing materials.
---|---

Description:

Parkell’s MucoHard+™ is a self-cured, pink gingival-colored, hardsetting resin, packaged in an auto-mix cartridge that is more convenient and faster to use than powder/ liquid systems. MucoHard+ is biocompatible, tasteless, odorless, esthetic, MMA-free, and has a low exothermic temperature for patient comfort during the initial intraoral self-curing stage. The MucoHard+ kit includes an adhesive bonding liquid that enhances the bond to underlying acrylics and extends the life of the reline.

Indications for Use:

MucoHard+ is indicated for hard relines, repairs and for additions to fulor partial acrylic dentures.
Contraindications:

• MucoHard+ should not be used on or by persons who are allergic or sensitive to methacrylate-based resins. Symptoms may include dermatitis or inlammatory reactions. Keep these materials away  from children.
• Uncured MucoHard+ is not for internal use and should not be swallowed or contact eyes or mucous membranes other than the intraoral tissues. If necessary, lush with copious water, discontinue  use and obtain medical care.
• MucoHard+ should not be used on anesthetized or sedated patients.
• MucoHard+ should not be used as a pick-up material for attachment components.
• MucoHard+ is not for use on lexible nylon-based materials such as  Flexite® or Valplast ® .

Precautions:

• MucoHard+ may generate a modest level of heat while curing intraorally which the patient may identify as either an increase in temperature or as a tingling sensation. The amount of heat or tingling, and the onset of either of these sensations, can vary from patient to patient. Prior to the MucoHard+ reline being placed in the patient’s
  mouth, the dentist and the patient should discuss the possibility of  onset of such heat or tingling, and the patient should be instructed to  immediately inform the dentist if and when they experience such heat or tingling, whereupon the dentist should immediately remove the denture from the patient’s mouth.

• The MucoHard+ adhesive bonding liquid can damage clothes,  countertops, looring, carpets, etc.

• To avoid lock-on when relining a full denture, block out any undercuts. When relining partials, block out any clasps with an appropriate material.

• Shelf life will be reduced if not stored properly. After initial use, store in a cool, dark place with the original cap tightly screwed on.

• Excessive or intense squeezing force on cartridge-based restorative materials may cause gun breakage or cartridge cracking.

• Any stated work times and set times are estimates. Factors that can inluence work/ set times include, but are not limited to, storage   condition, temperature, humidity, age of product, and/or when the cartridge was irst opened.

MucoHard+ Kit Contains:

• (1) 5 0 l m automix cartridge of MucoHard+ Reline Resin (reill hS641)
• (1) 15 ml bottle of MucoHard+ Adhesive Bonding Liquid (reill hS642)
• Large diameter mixing tips with blue-green base (reill hS496)
• Applicator brushes (reill hS495)
• Instructions for Use

Directions for Use and Clinical Tips:

|
---|---
This – or – This
Butt Joints| NOT This – or – NOT This
NOT Feather Edge

Cut the acrylic border so it will form a butt-joint with the reline material. Feather-edge joints will encourage debonding and chipping.

1. Clean and disinfect the existing acrylic denture.

2. Remove 1-2 mm of the existing acrylic denture base from the surface to be relined. For best peripheral bond, remove at least 1 mm of the border and create a butt joint (not a feather edge) between the new and old material. Rinse and thoroughly dry the prosthesis.

3. Transfer 2-3 ml of Adhesive Bonding Liquid with a disposable pipette into a dappen dish or similar container and immediately recap the adhesive liquid bottle to prevent evaporation. Apply a generous amount of the Bonding Liquid evenly on the inner surface (“intaglio”) of the denture with a disposable brush. Wait at least 2 minutes for the liquid to evaporate from the denture surface.

4. DOUBLE-BLEED THE CARTRIDGE: Place the MucoHard+ cartridgeinto any impression gun marked “DS-50/1:1, 2:1” Remove the shippingcap, but do not discard as you will be using it later to recap and resealthe cartridge. Bleed a small amount of material onto a pad to assurethat material is coming out of the oriices of both barrels (Figure 1).Aix a blue-green mixing tip to the cartridge and express a small amount of MucoHard+ through the tip onto the pad (Figure 2).
   Immediately after this second bleed, continue to express the materialinto the denture intaglio and spread evenly. Roll the material over all theborders. The chemical curing reaction begins immediately upondispensing during the second bleed. Therefore, loading and preparingthe denture for insertion into the patient’s mouth should be completed30 to 45 seconds from the start of the second bleed.
   CAUTION: To avoid having the material low down the patient’s throat when relining an upper denture, do not overload the prosthesis.

5. Position the patient in an upright position. Insert the denture into themouth and apply slight pressure to ensure complete adaptation to thetissue. While continuing to hold the denture in place, gently pull the lipsand cheeks to ensure they do not get trapped under the borders. Guide the patient into desired centric at the proper vertical dimension and muscle-mold the borders.

6. While MucoHard+ is in the patient’s mouth, the dentist should remind the patient to alert the dentist if they are feeling any heat or tingling sensation that is making them uncomfortable. Upon such notiication,  the dentist should be prepared to remove the denture immediately from the patient’s mouth. IMPORTANT NOTE: never let MucoHard+cure to completion in the mouth; maximum time (from dispensingto removal from the mouth) must not exceed (i) approximately 3minutes or (ii) when the patient indicates an increase in heat or tingling sensation from the relined denture, whichever occurs earlier. After removal, it will take an additional 5 minutes outside the mouth to fully cure. Technique Tip: Small voids in the reline can be illed immediately afterthe resin has fully set, but before removal of the air-inhibited layer by repeating Steps 4 – 7.

7. Remove the air-inhibited layer from the denture by scrubbing it with atoothbrush and mouthwash. Trim, adjust, and polish using burs and polishers labeled for use on hard denture acrylic.

8. Rinse the denture and deliver it to the patient with instructions for home care.

9. Wipe the original cartridge sealing cap to remove any excess material prior to placing it back onto the MucoHard+ cartridge. This willprevent possible cross-contamination of the base and catalyst.

Tips for Dental Practitioners for  Cross-Contamination Control:
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 when appropriate; 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 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. The cartridge and dispensing gun can be cleaned of debris with an EPA-registered low-level to intermediate-level hospital disinfectant.
The used mixing tip should be discarded, and the original cap should be reattached to the cartridge to re-seal until next use. 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”.

Disposal of Material:

Before disposal, the product should be fully mixed with the mixing tip, cured and then discarded in the general refuse. All cartridges and mixing tips may be disposed of in normal refuse.
Events: Reportable incidences should be reported to Parkell and the competent authority in which the user and or patient is established.
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 certiied to  ISO 13485

Explanation of Symbols Used:

| Professional use only
---|---
| Follow instructions for use
| Temperature limit
| • Store product tightly sealed  away from direct sunlight.
| Use-by date (expiration)
| Batch code
| Catalogue / stock number
**| Caution
| Flammable
| Serious health hazards
| Package contents
UDI| Unique
MD| Medical Device
| Do not use if package is damaged
| Single use only
**| Manufacturer
| 15 ml liquid
| 50ml Split Cartridge / paste
| Mixing Tip
| Applicator brush
| Dispensing pipette

A01183revA0522
Rx Only—product is intended for use by a licensed
dental professional. For Safety Data Sheet (SDS)
go to www.parkell.com
hS640, S641, S642
****Parkell, Inc.,
300 Executive Dr., Edgewood, NY 11717 USA
800-243-7446 • www.parkell.com

References

• Centers for Disease Control and Prevention
• Dental Instruments, Devices and Materials

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>