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OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures. The AtlantisTM 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.

OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm). OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants. Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.

Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: - replacing single and multiple missing teeth in the mandible and maxilla, ● - immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge, - especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective, - immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Atlantis Abutments: 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface. The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is 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.

Implants: OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used: - · To replace missing teeth in single or multiple unit applications within the mandible or maxilla - · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations - · For both one- and two-stage surgical procedures - · Especially well in soft bone applications where implants with other implant surface treatments may be less effective - · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants. OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations. To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.

Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.

The OsseoSpeed implants are intended to be used: - to replace missing teeth in single or multiple unit applications within the mandible or . maxilla - for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations - for both one- and two-stage surgical procedures o - especially well in soft bone applications where implants with other implant surface . treatments may be less effective - together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate - together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer - with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants. The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.

OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

The OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant, intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a microroughened and fluoride-modified surface, designated OsseoSpeed. It includes a contoured coronal margin that mimics the contour of alveolar bone and is designed to create a more desirable esthetic effect.

OsseoSpeed™ Narrow is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Narrow is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Osseospeed Narrow is a self tapping, threaded, root-form dental implant intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.