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| Name | Class |
|---|---|
| Aptiv Solutions | INDUSTRY |
| Pirkka Nummikoski, DDS, MS | UNKNOWN |
| CadBlu North (Hastings, MN) | UNKNOWN |
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The purpose of this research study is to document the use if the Keystone Dental Genesis Dental Implant System in standard clinical use and to provide 5 year survival data.
The technology behind dental implants is well established and the Genesis Dental Implant System has been cleared for marketing by the FDA. It is Keystone Dental's choice to collect post-market data within the framework of a clinical trial in order to assess the clinical performance of this device.
The risks of the Genesis Dental Implant System are no different than other comparable dental implant systems currently in use. Keystone Dental expects the clinical performance of this device to be equal to that of comparable implant systems.
The purpose of this research study is to assess the 5 year survival rate of the Genesis Dental Implant System, as well as assess the safety and effectiveness endpoints, which include incidence of adverse effects, change in bone height and soft tissue aesthetic outcomes.
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Inclusion Criteria:
Exclusion Criteria:
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Subjects between the ages of 18 and 85 who require dental implants
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Tarnow, DDS | Specialized Dentistry of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Coast Oral Facial Institute | Newport Beach | California | 92660 | United States | ||
| Brighton Periodontal & Implant Dental Group |
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| Woodland Hills |
| California |
| 91367 |
| United States |
| Periodontal Medicine & Surgical Specialists, LTD | Oakbrook Terrace | Illinois | 60181 | United States |
| Kevin G. Murphy & Associates, PA | Baltimore | Maryland | 21209 | United States |
| Specialized Dentistry of New York | New York | New York | 10155 | United States |
| Edwin Rosenberg, DMD, HDD, BDS | Philadelphia | Pennsylvania | 19102 | United States |
| PerioHealth Professionals, PLLC | Houston | Texas | 77042 | United States |
| Dental Design | Gainesville | Virginia | 20155 | United States |