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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.

For 3.0mm Intra-Lock® OP Dental Implants: The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function. For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants: Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either 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® OP Dental Implants are threaded dental implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with an integrated straight abutment (implant and abutment arc one piece).

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.

The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

The Intra-Lock Mini Drive-Lock™ Dental Implant System consists of machined Titanium, screw-form dental implants, 2.0mm and 2.5mm in diameter and available in lengths of 10mm, 11.5mm, 13mm, 15mm and 18mm. The implant raw material consists of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401). The implants are sterile packaged.

1. MILO™ Implants are indicated for long-term maxillary and mandibular tissuesupported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. 2. MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

The Intra-Lock MILO™ Dental Implant System consists of machined titanium, screw-form dental implants 3.0mm in diameter. They are available in lengths of 10mm, 11.5mm, 13mm and 15mm. The implants' raw material is Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS) R56401). The implants are sterile packaged.

Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth bridge applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.

The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous Dental Implants. They perform the function of connecting the laboratory fabricated prostheric bridge or crown to the implanted dental implant. They are manufactured from Titanium Alloy (6 Al-4V ELI, ASTM F136) and are provided in a number of sizes to accommodate tissue depth. These prositietic abutments are provided in non-sterile packaging.