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The ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments. The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use. The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.

The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.

The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs. The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.

The ACE Surgical Secure-Mini™ Implant System is intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients.

The ACE Surgical Secure-Mini™ Implant System is a set of machined surgical grade titanium alloy screws, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of 10, 11.5, 13, and 15 mm, in standard trays and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K951392. These screws are supplied sterile in standard Tyvek™ trays. The ACE Surgical Secure-Mini™ Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

The ACE Tru-FIX™ Implant System is a set of machined surgical grade titanium alloy (Ti-OAL-AV ELI) screws, intended to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects. The implants are supplied sterile in 3.0 mm and 15 mm, in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in the screw raw materials and characteristics to that cleared under K951392. These screws are supplied in ACE Surgical TRU-Fix™ trays. The ACE Surgical TRU-Fix™ Implant System is a comprehensive system retaining prosthetic components, if applicable, of the ACE Surgical Orthodontic Miniboneplate system.

The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

The ACE Surgical Orthodontic Screw System is a is a set of machined surgical grade titanium alloy (Ti-6AI-4V ELI) screws, intended for orthodontic use, constructed with a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. This head design also permits the use of the screw with the orthodontic appliances (bracket, wire, elastic head, etc.) The tip of the screw is designed available to self drilling and self-tapping, supplied in 1.2/1.5mm and 1.5/1.8mm tapered thread, both with a 3.0mm diameter head and in lengths of 6,8,10mm. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics that cleared under K951392. These screws are supplied sterile in standard Tyvek™ mylar packaging. The ACE Surgical Orthodontic Bone Screw System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material.

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is a medical grade calcium sulfate hemihydrate. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is designed to set-up in vivo. It is mixed with small amounts of regular saline solution to produce a putty-like paste and it is applied on bone defects in amounts of 0.5 cc to 5.0 cc. The setting of the paste over may be set using a small square of sterile gauze soaked in the fast setting solution. With time, the ACE SurgicalPlaster Calcium Sulfate Hemihydrate dissolves and recedes leaving behind spaces that have been found to stimulate bone in-growth.

The ACE CONNECT™ Internal Connection Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

The ACE Surgical Internal Connection Screw Dental Implant System is a machined commercially pure titanium screw form implant intended to be implanted into the upper or lower jaw to serve as an anchor for a fixed dental prosthesis or single tooth restorations, constructed with an internal hexagon feature for inserting the implant into its surgical site, and to stabilize the prosthesis for rotational load, used to reconstruct the dentition of a patient who is wholly edentulous, supplied in diameters of 3.75. 4.0. 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm. The implant raw materially pure titanium CP-4 as specified in ASTM F67-95 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications. The implant surface is roughened by means of a blast media process to aid in implant adhesion. The candidate devices are identical in materials and characteristics to that cleared under K954513. The ACE Surgical Internal Connection Screw Dental Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Screw Dental implant to assist with the implant's insertion and final prosthetic fabrication.

The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

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The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical Indications are as follows: - · Tumor Resections - Severe trauma which make continuous bone segments no longer possible - · Bone grafting defects - · Severe open mandibular fractures - · Facial deformity corrections

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.