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The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

The I Macro 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.

The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K090174. The I Macro Implant is available in a 6.0, 7.0, 8.0 & 9.0mm diameter and is available in 8, 10, and 12mm lengths.

The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

As an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. When splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function. For denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function when good primary stability is achieved and with appropriate occlusal loading.

A self-tapping CP Titanium or Titanium Alloy threaded screw, with light grit blasting or roughened surface treatment.