Section 1.0
IMPORTANT!

Read all instructions before use.

Caution! Federal law restricts the sale of Gingival Cuff Links to licensed dentists only.
It is the dental professional’s responsibility to determine clinical usage. GCL Systems 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. GCLSystems.com will have the most up to date information. Please review updates frequently or call toll-free at 833-425-4346 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:

Gingival Cuff links are a temporary healing cuff with an attached abutment. Gingival Cuff Links are intended for use with endosseous root-form dental implants for prosthetic rehabilitation. The cuff is for temporary use only. The Gingival Cuff Links design provides an ideal emergence profile during the healing process.
Placement of Gingival Cuff Links 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:

Gingival Cuff Links are intended for temporary use during the healing process. Place a permanent abutment and crown once healing is complete.
Gingival Cuff Links can only be used with dental implants and are not for use with dentures, natural tooth structures, or any other non-implant environment.
Gingival Cuff Links are contraindicated for use by patients with sensitivity or allergy to acrylics or titanium.
Gingival Cuff Link’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:

Gingival Cuff Links are for one-time use only. Do not consider or attempt reuse..

Section 1.8
Shelf Life:

Gingival Cuff Links 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:

Gingival Cuff Links are recommended for storage at room temperatures between 39° to 77°F or 4°C to 25°C. Handle Gingival Cuff Links 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 GCL Systems recommended utilization of the Gingival Cuff Links, 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 cuff.
4. Verify that the implant is appropriately oriented so that the implant connection is facing buccally to allow the Gingival Cuff Links insertion into the implant connection.
a. Most implant systems have a recommended orientation. Please review the implant system instructions for details.
5. Place the Gingival Cuff Links 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 Gingival Cuff Link.
b. When accurately seated the Gingival Cuff Links sit flush with the implant platform without resistance.
6. Consider utilizing an x-ray to verify seating of the Gingival Cuff Links.
7. The outer layer of the Gingival Cuff Links 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, Gingival Cuff Links.
8. Establish the final shape of the Gingival Cuff Links and finish to the desired texture.
a. Smooth surfaces will allow for limited to no bleeding of the gingival tissue, when the Gingival Cuff Links 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
Gingival Cuff Links have been developed for use in implant dentistry. The application information of Gingival Cuff Links delivered by GCL Systems 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 GCL Systems as to their suitability for use. The application of Gingival Cuff Links is entirely under the control of the dental professional’s responsibility for implementation and use. We guarantee the quality of our Gingival Cuff Links 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: gclsystems.com
Call Toll Free: 833-GCL-INFO (425-4346)
Hours: M-F 8 am – 5 pm MT

GCL Systems Inc.