Harvest EasyGum® - Instructions for Use

Modified on Fri, 7 Nov at 11:33 AM

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(en) Instructions for Use

Harvest EasyGum® Gingiva Esthetic Strips,

Modifiers and All-in-One Bond #9836

1 Overview

Product Description & Indications

Harvest EasyGum® is a filled, light-cured gingival composite system designed to reproduce natural gingival form, texture, and color on removable or fixed prosthetic bases.

The composite bonds to common printed or milled denture and framework materials, including polymethylmethacrylate (PMMA), resin-matrix composites containing nano-fillers, zirconium oxide (Harvest Nano® Zirconia), and metal frameworks.

The EasyGum™ Strip provides a pre-formed alternative to the labor-intensive process of hand-layering gingival composites, enabling faster and more uniform application. Fine anatomical detail and individualized shade effects can be achieved using EasyGum™ Modifiers for advanced surface texture and color depth.

The EasyGum™ composite matrix is a cross-linked methacrylate-based resin reinforced with inorganic microfillers and high-density pigments to provide excellent handling, polishability, and long-term color stability.

The strip is bonded to the prosthetic base using EasyGum™ All-in-One Bond, then light-cured with a standard dental curing unit or handheld light.

EasyGum™ is intended for use by a trained dental professional.

Material Indications Printed or Milled

PMMA, Polymers & Hybrid Resins

Zirconium Oxide Ceramics

Metal Substructures

Contraindications / Warnings

Do not use in patients with known allergies to methacrylate monomers.

Avoid contact with skin and eyes; use gloves, mask, and eye protection.

Maintain clean, oil-free surfaces throughout workflow.

Deviation from validated parameters may compromise bond strength or biocompatibility.

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.

2 Application

2.1 Preparing Gingiva Surface

This section covers substrate-specific cleaning and preparation prior to bonding.

Material Classes

PMMA, Polymers & Hybrid Resins

Zirconium Oxide Ceramics

Metal Substructures

Caution: Material must be completely dry prior to EasyGum™ Bond application.

PMMA, Polymers and Hybrid Resins

PMMA

Denture Base polymers

Nano-Ceramics

Hybrid composites

High-Performance Polymers

Air Abrasion: 50 µm Aluminum Oxide (Al₂O₃) @ 1.5–2.0 bar (22–30 psi), 90°, 10 mm, 5–10 s.
Ultrasonic Clean: Distilled water for 3 min.
Dry: ≥ 60 s with oil-free air until moisture-free.
Handling: Handle only with clean, oil-free tweezers or gloves.

Zirconium Oxide Ceramics*

Harvest Nano® Zirconia is the only zirconia currently validated for the Harvest EasyGum® workflow.

Air Abrasion: 50 µm Aluminum Oxide (Al₂O₃) @ 2.0–2.5 bar (30–35 psi), 90°, 10 mm, 5–10 s.
Ultrasonic Clean: Distilled water for 3 min.
Dry: ≥ 60 s with oil-free air until moisture-free.
Handling: Handle only with clean, oil-free tweezers or gloves.

Metal Substructures

Titanium

Chrome Cobalt

Air Abrasion: 50 µm Aluminum Oxide (Al₂O₃) @ 2.5–3.0 bar (35 psi), 90°, 10 mm, 10 s.
Ultrasonic Clean: Distilled water for 3 min.
Dry: ≥ 60 s with oil-free air until moisture-free.
Handling: Handle only with clean, oil-free tweezers or gloves.

2.2 EasyGum™ Bonding Protocol

EasyGum™ Bond (All-in-One) (#9835) is the only bonding agent validated for EasyGum™ workflow.

About EasyGum™ Bond (All-in-One)

EasyGum™ Bond is a single-bottle, light-cured bonding agent that combines etchant, primer, and resin in one step. It simplifies the workflow while delivering strong, reliable adhesion across all major prosthetic materials.

The bond works on two levels:

Micromechanical retention from surface air abrasion.
Chemical coupling through MDP-phosphate interaction.

This dual mechanism produces a high-strength, durable bond to:

PMMA, Polymers & Hybrid Resins

Zirconium Oxide Ceramics

Metal Substructures

Its advanced formula cures across a broad wavelength range (365–510 nm), making it compatible with both LED and halogen curing systems. Important: All bonding surfaces must be clean, dry, and uncontaminated before applying EasyGum™ Bond.

Bonding Steps:

Dispense a drop of EasyGum™ All-in-One Bond (#9835) into a clean mixing well.
Apply two wet coats evenly to the prepared surface; allow each coat to dwell for ~30 s.
Gently air-thin for 5-10 s. with oil free compressed air (~10 cm distance). Do not blast.
Light Activate using one of the following:

Curing Device	Wavelength (nm)	Intensity (mW/cm2)	Time Duration (sec)
LED Cure Box	365–490	≥ 1000	40 ~ 120
LED Handheld	400–510	≥ 1000	20
Halogen Unit	400–500	≥ 500	40

Bonding Notes

Cure Box: The light-curing duration will increase relative to the distance of the light source to the prosthetic.

When EasyGum™ is fully cured, it will not be sticky or tacky. The surface of EasyGum™ should be fully hardened. Press EasyGum™ with a metal instrument and check the surface for hardness.

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

2.3 EasyGum™ Strip Application

This section provides a comprehensive and detailed, step-by-step workflow for adapting, contouring, finishing, and polishing the EasyGum™ Strip after completion of bonding. Follow each step to achieve optimal adhesion, precise gingival form, and a lifelike esthetic finish.

Apply Intense Modifiers - Optional for higher esthetics

Using a stain brush, apply Intense Modifiers to the upper third of the tissue space to establish internal color depth.
Drag the flowable modifier down toward the cervical embrasures, allowing colors to blend naturally.
Light-cure 20 seconds per section across the arch. The cured surface will remain slightly tacky for strip adaptation.

Place the EasyGum™ Strip

Warm the strip by rubbing gently between gloved fingers (in its plastic sleeve) to increase flexibility.
Remove one protective film and align the strip at midline, edge-to-edge along the gingival arch.
Press and stretch from midline → distal using firm, even pressure to eliminate air pockets.
Greater pressure = greater translucency in thin zones.
Remove the remaining film once adapted and verify full contact.

Shape the Gingival Margins

Using the EasyGum™ Papilla Tool (#9832), press at the cervical junction and draw downward

to remove excess material and create scalloped margins.

2. Save trimmed excess in original black packaging & pouch for later use.

3. Confirm continuous, symmetrical margins before curing.

Refine Contour and Add Fine Details

Lightly dip the silicone tip in a small amount of EasyGum™ Bond to prevent sticking.
Push interdental papillae upward and round the peaks to mimic natural gingival form.
Smooth marginal transitions and verify curvature and balance under diffuse light.
Use an explorer to refine embrasures, remove localized excess, and add fine vertical lines or

stippling to replicate tissue texture.

5. Light-cure 20 s per section to preserve micro-detail.

2.4 Final Cure and Polymerization

EasyGum™ Strip cures without an inhibition layer. Therefore, no cover gel is needed.

LED Handheld:

Light-cure each segment 20–40 seconds.

For large prosthetics, cure sequentially in overlapping sections (central → distal → lingual).

Maintain the light tip ≤ 5 mm from the surface and perpendicular to the strip.

Verify that the surface is firm and fully polymerized.

LED Cure Box:

Cure-box duration increases with distance between light and surface.

Verify that the surface is firm and fully polymerized.

Curing Device	Wavelength (nm)	Intensity (mW/cm2)	Time Duration (sec)
LED Cure Box	365–490	≥ 1000	40 ~ 120
LED Handheld	400–510	≥ 1000	20
Halogen Unit	400–500	≥ 500	40

Post-Cure Contour and Shape

Once cured, verify the surface is firm and non-tacky.

Contour with fine diamond or carbide finishers at low speed under dry conditions.

Maintain gingival anatomy; avoid overheating or flattening high points.

2.5 Polishing & Finishing

Polish with a Stiff Bristle Brush

Apply Harvest Speed Polish with a stiff bristle brush.

Polish using medium pressure in circular motions until a uniform sheen develops and color depth appears.

Refine Texture and Edges with Felt Wheel

Apply Harvest Speed Polish® (#8525) to a felt wheel mandrel and polish gently with light-to-medium pressure.

Focus on finishing edges and marginal transitions to achieve a smooth, natural gloss.

Final High Gloss with Cotton Buff

Use a cotton buff with light pressure for the final high-gloss finish.

The finished EasyGum™ surface should display a lifelike translucency and natural soft-tissue luster.

Final Cleaning

Steam-clean the prosthetic to remove polishing residue.

Wash with mild dish soap and a soft bristle brush.

Towel-dry with a microfiber cloth and inspect under diffuse light for color uniformity and surface quality.

Technician Notes

Keep all surfaces clean, dry, and uncontaminated throughout the workflow.

For large arches, cure in overlapping segments to prevent shadowing.

Maintain tool cleanliness between steps to avoid pigment contamination.

The final EasyGum™ surface should present a soft matte-to-gloss gradient under indirect light, simulating natural tissue.

Safety Information

In the case of serious incidents related to the product, please contact Harvest Dental Products, LLC Website: www.harvestdental.com and your responsible competent authority.

The current Instructions for Use are available on the website at: www.harvestdental.com

Warnings

Observe the Safety Data Sheet (SDS) available at www.harvestdental.com

Contact with uncured material may have a slight irritating effect and may lead to a sensitization against methacrylates.

Customary medical gloves do not provide protection against the sensitizing effect of methacrylates.

Do not inhale grinding dust.

Storage, Expiration and Reuse:

Storage

Store EasyGum™ Strip and Modifiers in their original containers between 41°F (5°C) and 86°F (30°C). Keep away from direct sunlight.

Always close containers when not in use.

Expiration

The expiration date is printed on each container.

Do not use after this date—expired materials may compromise device performance.

Reuse

Single use only. Do not reuse any applied material.

Disposal:

Dispose of EasyGum™ Strips and Modifiers in accordance with local regulations.

Ensure all materials are fully cured and dry before disposal.

Disinfection and Sterilization:

Finished devices may be cleaned and disinfected using a 70% ethanol solution in water.

Do not sterilize devices made with EasyGum™ Strips or Modifiers.

Symbol Explanation:

Manufacturer		Manufacturing Date
Expiration Date		Protect From Sunlight
Storage Temperature		Lot Number (Batch)
Product Number		Medical Device
Instructions for Use		Prescription Use Only