CreoDent Solidex™ Customized Dental Abutment and Screw Version 1.6
Instructions for Use
Indication for use:
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
Implant surgery and restoration involve complex dental procedures. Appropriate and adequate training in proper technique is strongly recommended prior to implant use. Improper technique can result in implant failure and/or loss of supportive bone. Exposure to long-term use of bisphosphonate drugs may impact implant stability. Careful patient selection including consultant with the attending physician is strongly recommended prior to implant treatment. Excessive mobility, bone loss, or infection may indicate the implant is failing. Any implant which appears to be failing should be treated or removed as soon as possible. If removal is necessary, curette any soft tissue from the implant site and allow site to heal as though it were an atraumatic extraction.
Warning: Small Diameter implants and angled abutments are not recommended for the posterior region.
Caution: Federal Law (USA) restricts the sales of this device to, or on the order of a licensed dentist or physician.
The CreoDent® Solidex Customized Abutment and screw is a patient specific dental implant abutment placed and mounted to the implant with an abutment screw provided with the abutment. The abutment screw shipped with the product is intended to secure the abutment to the implant.
Abutment and Abutment Screw
The CreoDent Solidex Customized Abutment and screw is made of Ti-6A1-4V Eli titanium alloy for surgical implants applications meets ASTM F-136 Standard. The abutment screw is intended to secure the abutment to the implant. The abutment screw meets the implant manufacturer’s recommendation for torque. Tighten the abutment screw according to the recommended torque from the implant manufacturer. The Abutment Screw provided must be used. Do not replace with implant manufacturer’s screw.
Magnetic Resonance (MR) Safety Information:
CreoDent Solidex Customized Abutment has not been evaluated for safety and compatibility with the MR environment. It has not been tested for heating, migration, or image artifact in the MR Environment. The safety of CreoDent Solidex Customized Abutment in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
The CreoDent Solidex® Customized Abutment has not been evaluated for pyrogenicity. No claim is made related to pyrogenicity.
CreoDent Solidex® Customized Abutment and screw should not be placed if there is insufficient alveolar bone width and height to surround implant. Implants placed in the maxilla should not perforate the sinus. Insufficient availability of bone (minimum 1mm circumferential and 2mm apical), poor bone quality, poor patient oral hygiene, heavy smoking or use of chewing tobacco, and generalized diseases (diabetes, etc.) may contribute to lack of integration and subsequent implant failure. Severe bruxism, clenching, or overloading may cause failure of abutments and implants. Psychologically unstable patients may not represent good implant candidates. Clinicians should select patients whom they feel will be satisfied psychologically, as well as esthetically and functionally, with the restoration. Exposure to magnetic resonance imagining, radiation, and chemotherapy may impact health of the implant. Dental implant patients should be instructed to consult with their physician prior to such treatment options.
The following complications may occur: dehiscence, delayed healing, paresthesia, hyperesthesia, edema, hemorrhage, hematoma, infection, inflammation, and local and generalized allergic reaction.
Cleaning and Sterilization
- Place the components on a glass beaker
- Fill the beaker with instrument detergent concentrate and water (according to the detergent manufacturer’s instructions)
- Run the beaker in the ultrasonic cleaning unit for 5 minutes
- Rinse the components thoroughly in water
- Let each item dry completely
Place the dry components into an appropriately sized sterilization pouch designated for use with your sterilizer according to manufacturer’s instructions.
CreoDent Solidex® Titanium Customized Abutment and Abutment Screw
The abutment and abutment screw must be cleaned and sterilized prior to use. See above ultrasonic cleaning instructions. The components should be steam sterilized to a Sterility Assurance Level (SAL) to 10 -6 inside a pouch. FDA Cleared Sterilization Accessories are to be used for the recommended Sterilization parameters when wrapping the devices in a pouch.
Steam sterilizes the abutment and abutment screw at the following parameters validated under ANSI/AAMI ST: 79:2010.
The CreoDent Solidex abutment screw provided must be used.
Remove the cover screw or healing abutment (healing cap/healing cover) from the implant to expose the implant seating surface. Place the abutment on the implant. Do not force the abutment on to or into the implant surface. Connect the abutment to the implant, make sure the abutment is properly seated. Tighten the abutment screw with light finger force. An x-ray can be taken at the time to verify the abutment is fully seated. Tighten the abutment screw to the recommended torque. Follow implant manufacturer’s directions for torque level.
Implant, Abutment Screw or Abutment Failure
In case of implant, abutment screw or abutment failure, please observe the following instructions for abutment removal. If the abutment fails, remove the abutment, preserving all damaged parts and return to CreoDent for investigation. If there is also screw failure and/or implant failure, follow the instructions below:
If Abutment fails and the implant is intact:
- Remove crown (using standard crown removal protocols)
- Use screw removal tool to remove Abutment screw (standard tool-drill bit with reverse direction)
- Remove abutment
If implant fails:
- Remove crown (using standard crown removal protocols)
- If Abutment Screw is intact, remove with appropriate driver
- If Abutment Screw is also broken, it will fall out with removal of crown
- Follow standard protocol for removal and replacement of failed implant
*This information is provided for information purposes only and does not constitute legal advice, nor a legal contract between CreoDent Dental Prosthetics (“CreoDent”) and any person or entity. Although all reasonable effort is made to present accurate information, CreoDent makes no guarantee of any kind, including but not limited to that it may be outdated, invalid, or subject to debate. The information is provided “as is” without warranty of any kind, either express or implied, including and without limitation, the implied warranties of merchantability, fitness for use for a specific purpose.
**You agree that CreoDent Dental Prosthetics (“CreoDent”) will not be liable to you for any loss or damages, either actual or consequential, arising out of or relating to these terms, or to your (or any third party’s) reliance upon information (including torque recommendations) obtained from CreoDent. In particular, CreoDent will have no liability for any consequential, indirect, punitive, special or incidental damages, whether foreseeable or unforeseeable, arising out of or relating to these terms, or to your (or any third party’s) reliance upon information (including torque recommendations) obtained from CreoDent, whether based in contract, tort, statutory or other law, except only in the case of death or personal injury where and only to the extent that applicable law requires such liability.
“….to protect the peri-implant structures, it is imperative to have a long-standing, effective barrier as otherwise there bacteria could penetrate, affecting the primary stability, initial healing, or long-term success of implant-supported restorations…. Abrahammson et al. showed how the abutment material influenced height and quality of the tissues, whereby titanium and ceramic abutments caused formation of mucosal attachment and metal-ceramic abutments led to soft tissue recession and increased crestal bone resorption…. Superior material homogeneity, custom designing, ease of fabrication in addition to supporting poor tissue contours, and eliminating compatibility concerns of dissimilar metal alloys are the various advantages being offered by CAD-CAM technology….”
(Abichandani et al., Abutment selection, designing, and its influence on the emergence profile: A comprehensive review, European Journal of Prosthodontics, Vol. 1, Issue 1, 2013)
Stock Abutment Vs. CAD/CAM Customized Abutment
“….Stock abutments are cylindrical or divergent at most, which is clearly different from the emergence profile of natural teeth, hence providing compromised support to the proximal and labial peri-implant soft tissues. Rompen and colleagues experimented with a stock, gingivally converging abutment design, which resulted in the formation of extra soft tissues, but his findings could not be confirmed by others…. The CAD/CAM process optimally controls the geometry of the abutment including the position of the outline in accordance with the neighboring natural roots and the gingival margin, subsequently reducing the risk on cement remnants deep in the sulcus. The finish of the abutment is controlled, preventing sharp edges and the design can compensate for poor implant angulations….”
(Schepke et al., Stock Versus CAD/CAM Customized Zirconia Implant Abutments, Clinical Implant Dentistry and Related Research, Volume 19, Number 1, 2017)
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