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PrimaConnex SD Esthetic Contour Zi Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex SD Esthetic Contour 7: Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.

Lifecore's implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Lifecore Dental Implants are root-form, endosseous implants with a roughened surface. The modification proposed in this submission will modify the Resorbable Blast Media (RBM) implant surface to add a micro-texture surface morphology to the existing macrotexture. The change to the RBM surface will be incorporated into all Lifecore implant systems that have the RBM surface (Restore, Stage-1, Renova, PrimaSolo and PrimaConnex).

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations. The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.

Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration. The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).

The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.

The Stage-1 ** Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.

Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone. The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction into the extraction socket. The PrimaConnex Internal Connection Implant is intended for immediate provisionalization with non-occlusal load. Immediate Provisionalization is described by the International Congress of Oral Implantologists (ICOI) as a clinical protocol or the placement of an interim prosthesis with or without occlusal contact with the opposing dentition at the same critical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Specific Intended Uses: The PrimaSolo One-Piece (3.5 – 5.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and cemented restorations. It is intended for immediate placement and can be restored with a temporary prosthesis in single tooth applications with good quality bone. The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for Single-Stage procedure and is indicated for use in the treatment of missing maxillary lateral and mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The implants must be splinted if using two or more 3.0mm implants adjacent to one another.

The Lifecore PrimaSolo™ One-Piece Implant System is a one-piece implant incorporating both the implant and the abutment into one piece of machined titanium allov. It is designed for one-stage surgical procedures and utilizes cement-retained restorations. It is designed to be used for immediate placement and temporization on single and multiple-tooth restorations. The system also includes healing caps and surgical instrumentation: tissue punches, twist drills, surgical taps, parallel pins, try-ins, surgical depth probe, latch-type implant drivers, and ratchet adapters . Lifecore PrimaSolo One-Piece Implants are available with a Resorbable Blast Media (RBM) roughened surface.

CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as: - Intrabony/infrabony defects . - Furcation defects . - Recession defects . - Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ● - Extraction socket (ridge preservation) defects . - Ridge augmentation defects . - Sinus lift defects . - Endodontic bony defects .

Lifecore Biomedical Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate material that contains resorbable surgical grade plaster of paris with approximately 10% of a pharmaceutical grade sodium carboxymethylcellulose (CMC). The Binder is a white, free-flowing powder. Calcium sulfate (CS) hemihydrate and PHARMACEUTICAL grade sodium carboxymethylcellulose are commercially available as raw materials for use in several orthopedic and dental devices. Calcium sulfate/CMC, when used in conjunction with demineralized bone matrix (DBM), controls the particles in the bony defect where bony walls may be insufficient to stabilize the graft. It increases the graft volume, and reduces particle migration during the early healing phase. CalMatrix remains pliable after mixing which allows the clinician an extended time period to complete the bone regeneration procedure.