The Gum Shaper design is unique in the market due to the “T” handle guide, fully sculptable material and user-friendly utility, resulting in optimal outcomes. Gum Shapers are entirely compatible with temporary crowns and flowable composite. Our goal is your complete satisfaction. If you need assistance, please contact us at 801-549-0670 (8am-5pm MST) or go to our Contact page and fill out the form. Proudly made in the USA.
Instructions for use
Gum Shapers are designed as a unique healing gingival cuff that allows the dental professional to easily shape and form tissue to the proper emergence profile during first or second stage surgery or any time during the healing process. Our Gum Shapers are adjustable to the correct size and shape of the replaced tooth to conform seamlessly to the individual patient esthetics. Sculpting Tissue…One Time! The Gum Shapers have eleven anatomic forms available to imitate the natural tooth shape.
Section 1.0
Section 1.2
Section 1.4
Section 1.6
Section 1.8
Section 2.0
Section 2.2
Section 2.4
Disclaimer
Section 1.0
IMPORTANT!
Caution! Federal law restricts the sale of Gum Shapers to licensed dentists only.
It is the dental professional’s responsibility to determine clinical usage. Esthetic Implant Solutions accepts no liability whether expressed or implied and shall not be held liable for direct, indirect, punitive, or other damages resulting from or in conjunction with errors in practice or judgment. Users are obligated to keep informed and follow all instructions. Gumshapers.com will have the most up to date information. Please review updates frequently or call 801-549-0670 for assistance.
The Gingival Cuff Links are not sterile. Sterilization must take place before use. See section 2.2 for sterilization requirements.
Gingival Cuff Links design is intended for use with individual implant systems and platform sizes. Please confirm the correct compatible SKU’s in use. A complete SKU list is available at GCLSystems.com.
For best practices and implant success, patients should avoid occlusal pressure.
Section 1.2
Indications for Use:
Gum Shapers are a temporary healing cuff with an attached abutment. Gum Shapers are intended for use with endosseous root-form dental implants for prosthetic rehabilitation. The shaper is for temporary use only. The Gum Shapers design provides an ideal emergence profile during the healing process.
Placement of Gum Shapers usually occurs at the first or second stage of implant surgery; however, the installation may take place at any time in the healing process.
Section 1.4
Contraindications:
Gum Shapers are intended for temporary use during the healing process. Place a permanent abutment and crown once healing is complete.
Gum Shapers can only be used with dental implants and are not for use with dentures, natural tooth structures, or any other non-implant environment.
Gum Shapers are contraindicated for use by patients with sensitivity or allergy to acrylics or titanium.
Gum Shapers’s proprietary “T” System allows for proper placement for ideal emergence profiles. Please follow all instructions for successful healing.
Section 1.6
Single Use Packaging:
Gum Shapers are for one-time use only. Do not consider or attempt reuse.
Section 1.8
Shelf Life:
Gum Shapers are considered viable for use up to 24 months after the manufacture date. The first six digits in the lot number on the package is in a YYMMDD format.
Section 2.0
Storage & Handling:
Gum Shapers are recommended for storage at room temperatures between 39° to 77°F or 4°C to 25°C. Handle Gum Shapers as minimally as possible.
Section 2.2
Sterilization:
Product is delivered unsterilized. Sterilization must occur before use. It is required to utilize a steam autoclave at 250° to 273°F OR 121° to 134° C. Time will vary depending on the size of the load and autoclave. Read autoclave instrument instruction manual for details.
Section 2.4
Instructions for Use:
The following necessary steps are Esthetic Implant Solutions recommended utilization of the Gum Shapers, however, should not supersede the expertise of the clinician.
1. Check to ensure the correct abutment connection type for the placed implant system is used.
2. Verify that the platform of the implant and the connection is clear of debris.
3. Consider contouring bone that may prevent a natural emergence profile in order to support proper seating of the shaper.
4. Verify that the implant is appropriately oriented so that the implant connection is facing buccally to allow the Gum Shapers insertion into the implant connection.
a. Most implant systems have a recommended orientation. Please review the implant system instructions for details.
5. Place the Gum Shapers into the implant site to determine if the healing cuff requires sculpting.
a. Removal of acrylic should be done subsequently to allow for proper seating of the Gum Shaper.
b. When accurately seated the Gum Shapers sit flush with the implant platform without resistance.
6. Consider utilizing an x-ray to verify seating of the Gum Shapers.
7. The outer layer of the Gum Shapers may be sculpted by either removal of acrylic or by adding flowable composite or bis-acrylic to achieve the desired contour.
a. Sculpting may include fabrication of a temporary crown out of, or on, Gum Shapers.
8. Establish the final shape of the Gum Shapers and finish to the desired texture.
a. Smooth surfaces will allow for limited to no bleeding of the gingival tissue, when the Gum Shapers removal takes place for the restorative phase of treatment.
9. Before final seating, all contact should be checked to verify that there is no functional occlusion or interproximal pressure to ensure implant success.
10. Once placement is complete, tighten the screw to the implant manufacturer’s recommendation followed by closure of the access channel with the appropriate materials.
11. Include component label information in the patient record.
Disclaimer
Gum Shapers have been developed for use in implant dentistry. The application information of Gum Shapers delivered by Esthetic Implant Solutions has been given to the best of our knowledge and without obligation. Our information or advice does not relieve the consumer from examining the materials distributed by Esthetic Implant Solutions as to their suitability for use. The application of Gum Shapers is entirely under the control of the dental professional’s responsibility for implementation and use. We guarantee the quality of our Gum Shapers in compliance with the existing standards and corresponding to the conditions as stipulated in our general terms of sale and delivery.
For more Information:
Website: gumshapers.com
Call: 801-549-0670
Hours: M-F 8 am – 5 pm MT
Esthetic Implant Solutions, LLC
