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CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

CeraRoot is an endosseous zirconia implant that incorporates both the implant and abutment into a one-piece design, and is intended for use in prosthetic dentistry to support single or multiple tooth restorations. The main characteristics of the CeraRoot implant are its extreme hardness, and ability to be fabricated into final net shapes with very tight tolerances via state-of-the-art CNC processing. The implants are single use devices and are delivered in sterile condition having been sterilized using ethylene oxide (EtO). Depending on the particular tooth to be replaced, CeraRoot implants are made available in five different implant shapes: Wide Upper Central Incisor & Cuspid, Upper Central Incisor & Cuspid, Upper Lateral & Lower Incisor, Bicuspid, Molar; four different implant lengths: 8, 10, 12 & 14 mm; and five different implant diameters: 3.5, 4.1, 4.8, 6, & 6.5 mm. The CeraRoot implants have similar indications to the predicate devices produced by Z-Systems and Nobel Biocare, are made of virtually identical materials (i.e., zirconia that is at least 95% by weight Z.O.) and are available in similar lengths and diameters. The primary difference in the CeraRoot implants and the predicate devices lies in their overall shapes, surface finish and threaded areas. The CeraRoot implants are made available in five different unique shapes that have been designed for specific areas of the mouth, and use a color coding method that matches the correct implant shape to the location in the mouth where it is to be placed. The CeraRoot implants are also subjected to an acid etching process called ICE -surface that is used to impart the unique surface finish to the device that helps to enhance the osseointegration process. This compares to the more conventional mechanical processes that are imparted to the surfaces of the predicate devices. Additionally, the CeraRoot 14 Bicuspid implant is designed to be press-fit into place, as only the coronal half of the endosseous implant contains threads. The surgical method by which this implant is placed requires that it be tapped into place, with no rotational aspect to the insertion as compared to all the remaining implant shapes, which are surgically inserted by conventional means (i.e., screwed into place). This design is unique to the CeraRoot 14 Bicuspid implant only, and is not found on any of the other predicate implants.