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The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

The Intra-Lock Bone Fixation System consists of titanium alloy self-tapping screws, which are tapered and have a minimum diameter of 1.5mm with lengths of 3mm, 6mm, 7mm, 8mm, 9mm, 10mm and 11mm and a maximum diameter of 2.0mm with lengths of 4mm, 5mm, 9mm, 11mm, 13mm, and 15mm. Tenting screws are also available in the 1.5 mm diameter. The spacer part of the tenting screws is available in 2mm, 6mm, 8mm and 10mm lengths. The screws are manufactured using Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes accessories used to fixate the screws, membranes or bone graft to the host bone including a tapered driver, and a cassette. The screws are designed for removal from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single-use only.

Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.

Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.

ReOss" Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue. ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel. Products are provided in sterile packaging in various dosage volumes.