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Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration. The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961. The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings. The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.

The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.

Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission. In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.

Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients. Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for: - Fixed partial dentures/splinted units (one implant per unit) - Pontic cases in combination with at least one longer implant - Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution. This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222. The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.

Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs. The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.

Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated. Temporary Abutments have a maximum duration of usage of 180 days.

The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.

ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited ( minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITT 4.1mm dental implant. ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the healing phase and helps stabilize and maintain the soft tissue. The ITI synOcta angled abutments for Wide Neck Implants are in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge. ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures. The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations. ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases. The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed. The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture. The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges. RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended after orthodontic treatment has been completed. Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant. Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations. The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the healing process for us to six months and should be placed out of occlusion. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns. bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained or directly veneered. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability; small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.) The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months. The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months. The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 0 4.8 mm and WN (Wide Neck) 0 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants. The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Straumann® dental implants are suitable for the treatment of oral and endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. The Strauman® CARES® Screw-retained Bridge Titanium and Strauman® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide Neck (WN) 06.5mm) in the treatment of partially edentulous jaws for the purpose of restoring chewing function. The Strauman® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Strauman® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetions such as crowns, bridges and overdentures. The Strauman® CARES® Variobase ™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase TM Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase TM Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. The Strauman® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase TM Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion. Straumann® dental Implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental Implants can also be used for Immediate or early Implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the Implants by the corresponding elements (abutments). When placing in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Closure Screws, healing caps, and healing abutments, are Intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the Implant and maintain, stabilize and form the healing process. Customizable healing abutments made of PEEK are for use for up to six months. The Straumann Variobase,. Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase. Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw retained restorations. The Strauman® Magellan TM abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan™ abutments are indicated for screw-retained restorations. Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations. Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). The Strauman® Screw Retained Abutments are indicated to be placed into the implants of the Strauman® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw-Retained Abutments are indicated for screw-retained restorations. The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained. Straumann dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentuly dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth, Implants can be placed with immediate function on single-tooth and /or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cementretained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. Straumann® Bone Level Tapered Implants ②2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ②2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobas® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained. Straumann Screw retained Abutments are indicated to be placed into the implants of the Straumann Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann Screw Retained Abutments are indicated for screw-retained restorations. This abutment system is intended to be used in conjunction with ITI endosseous dental implants to provide support for prosthetic devices (crowns, bridges, overdentures) for the functional and oral rehabilitation of edentulous or partially edentulous patients. The Memfix Screws are intended to be used to temporarily stabilize and fixate autogenous bone grafts and/or nonresorbable barrier membranes used for regeneration of bone in the oral cavity. Titanium healing caps are indicated for use with ITI Dental implants. They are used to allow the site to heal The modified angled abutment is indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15 degree angled implant as the total degree of angulation is 30 degree or above. The angled abutment is not to be used in conjuction with the Ø3.3 mm Solid Screw Implant for single, posterior restorations. Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment. The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retro-molar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cvlinders provide a machined or cast inner surface for mating with the abutment and implant. while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase. The synOcta® angled abutments are indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited ( minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITT 4.1mm dental implant. ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the healing phase and helps stabilize and maintain the soft tissue. The ITI synOcta angled abutments for Wide Neck Implants are in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge. ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures. The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations. ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases. The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed. The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture. The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges. RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended after orthodontic treatment has been completed. Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant. Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations. The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the healing process for us to six months and should be placed out of occlusion. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns. bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained or directly veneered. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability; small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.) The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months. The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months. The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 0 4.8 mm and WN (Wide Neck) 0 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants. The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Straumann® dental implants are suitable for the treatment of oral and endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. The Strauman® CARES® Screw-retained Bridge Titanium and Strauman® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide Neck (WN) 06.5mm) in the treatment of partially edentulous jaws for the purpose of restoring chewing function. The Strauman® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Strauman® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations. Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetions such as crowns, bridges and overdentures. The Strauman® CARES® Variobase ™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase TM Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase TM Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. The Strauman® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase TM Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant. Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion. Straumann® dental Implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental Implants can also be used for Immediate or early Implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the Implants by the corresponding elements (abutments). When placing in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Closure Screws, healing caps, and healing abutments, are Intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the Implant and maintain, stabilize and form the healing process. Customizable healing abutments made of PEEK are for use for up to six months. The Straumann Variobase,. Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase. Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw retained restorations. The Strauman® Magellan TM abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan™ abutments are indicated for screw-retained restorations. Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations. Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). The Strauman® Screw Retained Abutments are indicated to be placed into the implants of the Strauman® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw-Retained Abutments are indicated for screw-retained restorations. The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained. Straumann dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentuly dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth, Implants can be placed with immediate function on single-tooth and /or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cementretained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. Straumann® Bone Level Tapered Implants ②2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ②2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobas® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained. Straumann Screw retained Abutments are indicated to be placed into the implants of the Straumann Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann Screw Retained Abutments are indicated for screw-retained restorations. This abutment system is intended to be used in conjunction with ITI endosseous dental implants to provide support for prosthetic devices (crowns, bridges, overdentures) for the functional and oral rehabilitation of edentulous or partially edentulous patients. The Memfix Screws are intended to be used to temporarily stabilize and fixate autogenous bone grafts and/or nonresorbable barrier membranes used for regeneration of bone in the oral cavity. Titanium healing caps are indicated for use with ITI Dental implants. They are used to allow the site to heal The modified angled abutment is indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15 degree angled implant as the total degree of angulation is 30 degree or above. The angled abutment is not to be used in conjuction with the Ø3.3 mm Solid Screw Implant for single, posterior restorations. Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment. The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retro-molar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cvlinders provide a machined or cast inner surface for mating with the abutment and implant. while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase. The synOcta® angled abutments are indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. lmplants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. The Straumann® Dental Implant System includes various dental implants with different sizes and surfaces (SLActive® and Roxolid®). Straumann® Dental implants are solid screw implants manufactured from titaniumzirconium alloy (Roxolid®) or titanium Grade 4. The implant surface is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm. The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm. The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN. There are three components to the Straumann® SC Variobase™ Abutments: - Straumann® SC Variobase™ Abutments (Ti-base) - Prosthetic restoration (coping and/or crown) - Basal Screw The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw. The following is an overview of the possible prosthetic restoration (coping and/or crown) materials: - Cast materials: - Type 4 metals (ISO 22674) - Base metal alloys (e.g., cobalt-chromium (CoCr)) - Noble metal alloys (e.g., gold alloy) - Press materials: - IPS e.max® Press Ceramic (K120053) - Digital materials: - coron® - zerion® LT - polycon® ae All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.