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LoFric® Primo™ and LoFric® Hydro-Kit™ are intended for intermittent urinary catheterization.

The LoFric® Primo™ and LoFric® Hydro-Kit™ are single-use catheters designed as intermittent pathways for drainage of the bladder. The catheters are available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available. Each catheter is packaged along with a water packet that is to be broken immediately before use in order to soak the tubing.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mm Implants Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

The device covered in this submission is a single restorative component for dental implants that integrates all aspects of the coping and abutment functionalities. The device has a crown shape exterior which allows the porcelain to be applied directly to the surface of the screw retained abutment and provides support for the described prosthetic restoration. The Atlantis Crown Abutment in Zirconia design is different than an Atlantis Abutment for cement-retained restoration in that the basis for its individualized design is the final crown. The subject crown abutment is indicated for screw retained restorations. The Atlantis™ Crown Abutment in Zirconia is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI and complies with ASTM Standard F-136. The zirconia screw retained abutments are placed over the implant shoulder and are mounted into the implant with the titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants. The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Camlog Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm. 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes. In addition. the Atlantis™ Abutment for Camlog Implant for the 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The Atlantis Abutment in Zirconia is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angulated abutments on small implants are intended for the anterior region of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant for the Astra Tech Osseospeed Profile 4.5, 5.0 and 5.0 S Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets SO Standards 6972 & 1356). Zircomia may have variation in shade. The abutment serew is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos Implants: Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Dentsply Ankylos Implant and abutment screw are made from Titanium grade Ti-6A 1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.5mm, 5.5mm, and 7.0mm sizes. The titanium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants. The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants. The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Dentsply Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the mandible or maxilla. The prosthesis can be cement and screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Nobel Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedyTM 3.5mm implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. Zirconia may have a variation in shade. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Nobel Replace Implants and abutment screws are made from biocompatible yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6872 & 13356 and may be produced in any composition complying with the values specified by these standards.. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Nobel Replace® Straight Groovy 3.5mm. Nobel Replace® Select Tapered and Straight 3.5mm, and NobelSpeedy™ 3.5mm implants.

The Atlantis Abutment is intended for use with an 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 prosthesis, 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Straumann Bone Level Abutment and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm, 4.1mm and 4.8mm sizes. In addition, the Atlantis™ Straumann Bone Level Abutment for the 4.1mm and 4.8mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The Atlantis Abutment is intended for use with an 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 prosthesis, in the maxillary lateral incisors and mandibular lateral and central incisors. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.0 mm OsseoSpeed™ Implants.