Harvest EasyGum® and All-in-One Bond - Instructions for Use

(en) Instructions for Use – EasyGum™ Composite Strips (for All-in-One Bond, see below)

Indications 

Harvest EasyGum® is indicated for adding texture and color to the gingival area of a dental base for removable dentures. This composite is bondable to typical acrylic denture resins used for making bases, such as polymethylmethacrylate (PMMA), as well as metals and ceramics (zirconia). The EasyGum™ Strip is an alternative to the laborious method of using a shaded composite paste to manually build up and model visible gingival surfaces to look similar to natural gingival issues. Additional texturization and coloration can be added using various shades of EasyGum™ Modifiers. The Strip is bonded to the base utilizing EasyGum™ Bond, and after any final detailing is to be cured utilizing a typical light curing device. EasyGum™ is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient. 

Contraindications:

EasyGum™ may only be used for its intended purpose. Any other use is strictly prohibited, and sole responsibility lies with the user. This product must not be used in patients with known allergies to any of its ingredients. 

Composition:
EasyGum™ Strip: Urethane methacrylate, Di methacrylate, trimethacrylate, pyrogenic silica.
EasyGum™ Modifier: Urethane methacrylate, dimethacrylate, trimethacrylate, pyrogenic silica.
 EasyGum™ Bond: Refer to Adhesive Instructions for Use.

Hazard and Precautions:
  Danger:
• Causes skin irritation
• May cause an allergic reaction
• Causes serious eye irritation
• Wear protective gloves, protective clothing, eye protection, face protection 

First Aid:
•If on skin, wash with plenty of water
•If in eyes, rinse cautiously with water for several minutes. Remove contact lenses, if possible, and continue rinsing for several minutes
•If swallowed, immediately call poison center. 

Caution:
 Any unauthorized changes to the process, workflow, materials, equipment, parameters, or software may result in a device that is out of specification and is not recommended. Contact harvest@harvestdental.com for a current list of compatible components.  

Use Instructions 

A. Cleaning 
    Roughen up base surface to be covered using a crosscut bur or sandblasting with aluminum oxide to enhance adhesion. Thoroughly clean to remove any dust and debris. 

B. Preparing for Bonding 
    Apply and prepare EasyGum™ Bond to bonding areas according to Instructions For Use (for All-in-One Bond, see below). If desired, gingival characterization of the dental base material utilizing EasyGum™ Modifiers can be completed now prior to the application of the Strip.  

C. Application 
   Select EasyGum™ with the desired shading that, when cured, matches natural gingival issues. Cut the Strip to roughly the overall size needed and apply to the base with minor pressure to attain basic adhesion. 

D. Trimming and Finishing 
    Trim the Strip to the desired shape, and finish with typical hand tools to include the appropriate features such as the gingival line and interdental papilla. EasyGum™ Modifiers can be applied and modelled for additional texture and enhanced coloration to closely resemble the natural gingiva. 

E. Light Curing 
    Light cure using a standard dental light curing unit according to the following and the light manufacturer’s
     instructions:  

  In cases where the gingival area is large and using a directed light source, light-cure the Strip in segments. 

F. Contouring and Polishing
 After light-curing, contour, and polish EasyGum™ as needed using typical methods. 

Storage Conditions, Expiration Date and Reuse Material:
EasyGum™ Strip and Modifiers must be stored in their original containers between 41°F (5°C) and 86°F (30°C) and protected from direct sunlight. Keep containers closed when not in use.
The expiration date of the product is displayed on the container. Use after the expiration date is strictly prohibited and could lead to finished devices with inadequate properties. 

Disposal: 
Dispose of EasyGum™ Strip and Modifiers according to local regulations. Materials should be fully cured/dried prior to disposal. 

Disinfection and Sterilization:
If necessary, finished devices made using EasyGum™ may be cleaned and disinfected using a 70% ethanol solution in water. Devices made using this product are not to be sterilized. 

Labeling: 

Manufactured by:  Harvest Dental Products 905 Columbia St, Brea, CA 92821
714-674-7400 sales@harvestdental.com\

(en) Instructions for Use – All-in-One Bond (for EasyGum™  Composite Strips, see beginning of document)

Description

EasyGum™ Bond is a single bottle bonding system for use in bonding light-cured composite (Harvest Dental EasyGum™) to polymethylmethacrylate (PMMA), metal and ceramic (zirconia) dental prostheses. EasyGum™ Bond combines the etchant, primer and bonding resin into a single component. Through the elimination of components and steps within the application protocol, EasyGum™ Bond is extremely easy to apply and has little to no technique sensitvity. EasyGum™ Bond provides: easy application, consistent results, and best in class bonding in a single bottle.

Indications for use:
Indirect Restorations: bonding light-cured composite (Harvest Dental EasyGum ® ) to polymethylmethacrylate (PMMA), metal and ceramic (zirconia) dental prostheses.

Storage:
 Protect from sunlight. Store between 2°C/36° F and 30°C/86° F. See individual component labels for specific expiration dates.

Cautions:
 Avoid contact with eyes. If the material comes into contact with the eyes, flush with copious amounts of water and seek medical attention. Unpolymerized resins may cause skin sensitization in susceptible persons, in case of contact with the skin, wash thoroughly with soap and water.

General Instructions:

1. Rinse the preparation thoroughly and remove any pooled water. Leave moist.
2. Dispense a drop of EasyGum™ Bond into the cavity of the enclosed mixing well. Using a bristle brush applicator, apply 1 coat of EasyGum™ Bond to the entire preparation to be bonded to allow material to dwell for twenty seconds. DO NOT DRY.
3. Using the remaining material in the well and same applicator, apply 2 additional coats of EasyGum™ Bond.
4. Dry the surface thoroughly. Do not blast the surface with air or use suction as this could remove material from the surface and lead to debonding.
5. Light-activate for ten seconds. EasyGum™ Bond can be activated with any dental activation light.
6. Continue procedure with EasyGum™ Strip and Modifiers following EasyGum™ Instructions For Use.

Notes:

1. Although it is not critical to the success of Harvest Universal Adhesive, it is recommended that the preparation be cleaned with Clean and Boost (Gel or Liquid, Vista-Apex) prior to beginning the bonding protocol.
2. Pumicing or gentle particle abrasion of preparation is also recommended.
3. EasyGum™ Bond is always light-activated before placing EasyGum™.
4. Visit harvestdental.com for SDS.

Labeling:

Harvest Dental Products 905 Columbia St, Brea, CA 92821
714-674-7400   sales@harvestdental.com\

FRM-IFU-10 Rev. 02                                                                                         For Professional Use Only  Only

Updated> Sept 4th, 2024