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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.

The provided text is a 510(k) Premarket Notification from the FDA regarding "MRI Compatibility for Existing Straumann Dental Implant Systems." This document primarily lists indications for use for many different Straumann dental implant components and states the device's regulatory classification. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm-only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory approval letter and accompanying indications for use, not a clinical study report or a technical performance evaluation.

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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.

The provided text describes a 510(k) Pre-Market Notification for the Straumann® Dental Implant System. It does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria. Instead, it details a change to the Instructions for Use (IFU) by removing Type II Diabetes and patients previously irradiated in the head and neck from the Cautions/Precautions.

The document discusses performance data but it is a review of published literature to support the change in IFU, not a study performing specific tests against acceptance criteria for the device itself.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used for a test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided document indicates that:

• Bench and animal performance testing was previously submitted in support of referenced predicate devices and deemed representative of the subject devices (Section 5.7). This implies that past studies covered the initial performance metrics, but the details of those studies and their acceptance criteria are not in this document.
• Performance data (for the IFU change): A review and summarization of published literature was conducted regarding dental implant treatment in patients with Diabetes Mellitus (DM) and patients previously irradiated in the head and neck area to justify removing these conditions from "Cautions/Precautions." This involved survival rates and adverse events from existing literature.

While the document references "performance data," it is not structured as an acceptance criteria study report for the device's functional attributes but rather a clinical literature review to justify a labeling change.

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Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches 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. 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 through the corresponding components (abutments).

The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm

Here's a breakdown of the acceptance criteria and study information for the Straumann® Dental Implant System SLActive and Roxolid Product Families, based on the provided 510(k) summary (K130222):

1. Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a change in Indications for Use, not for a new device requiring performance metrics against specific acceptance criteria for a new product. The device itself (Straumann® Dental Implants) is already cleared and its performance is established through prior submissions.

The "acceptance criterion" in this context is primarily focused on demonstrating substantial equivalence to predicate devices and supporting the modification of the indications for use. This modification specifically aims to remove a limitation on the number of implants required for immediate loading in fully edentulous patients.

Therefore, the "reported device performance" relates to the clinical justification for this change, rather than numerical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a new clinical trial with a "test set" for a device. The study described is a clinical literature review. Therefore, the "sample size" is the cumulative patient data across the various clinical studies analyzed within the literature review. The exact number of patients or studies included in the review is not specified in this 510(k) summary.
• Data Provenance: The data provenance is from clinical literature, which typically includes studies conducted in various countries; specific countries are not mentioned. The studies would be retrospective and prospective in their original design, but the analysis presented here is a retrospective review of existing publications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: This aspect is not directly applicable to this type of submission. The "ground truth" for the modified indication is established through the body of scientific evidence in peer-reviewed clinical literature and professional consensus statements.
• Qualifications of Experts: The "experts" whose opinions form the basis of the mentioned consensus statements (American Dental Association, McGill Consensus, York Consensus) would be recognized leaders and specialists in dentistry and implantology. Their specific qualifications (e.g., years of experience as a radiologist) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no "test set" in the sense of a set of cases requiring independent expert review and adjudication for a device's performance. The clinical literature review relies on the outcomes and conclusions reported in peer-reviewed publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases with and without AI assistance. This 510(k) is about an implant system and its indications for use, not an interpretation aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No, a standalone study was not done. This device is a dental implant, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for justifying the change in indications for use is based on:

• Clinical Literature Evidence: Published clinical studies and data demonstrating the efficacy and safety of two immediately loaded dental implants for fully edentulous patients.
• Expert Consensus Statements: Formal recommendations and conclusions from recognized professional bodies (American Dental Association, McGill Consensus, York Consensus) in the field of dental implantology.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission concerns a physical medical device (dental implants) and a change to its indications for use, not an AI algorithm that requires a training set. The "training" for the device's original clearance and subsequent sustained use comes from years of clinical practice and research.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" in the context of this device and submission type. For the original clearance of the implants, ground truth would have been established through pre-clinical testing (bench, animal) and clinical trials (human studies) demonstrating safety and effectiveness, based on recognized clinical outcomes and expert assessment.

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Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches 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. 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 through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

This premarket notification serves to affect a labeling change applicable to all endosseous dental implants of the Straumann® Dental. Implant System. The subject devices are physically identical to the listed predicate device descriptions are identical to those presented in the referenced predicate submissions.

The proposed Straumann Implant Instructions for Use (IFU) changes in this premarket notification are to address the following:

• Update the IFU content to reflect the FDA Guidance on Medical Device Patient . Labeling regarding contraindications, general warnings, and precautions
• Clarify the term "poor bone metabolism" under contraindications and move the . condition "osteoporosis" to Precautions in the IFU
• Modify the indications for use statement previously cleared in premarket notifications . K081419 and K083550 to relocate the statement regarding specific indications for small diameter (Ø3.3 mm) implants from the indications for use to the Precautions

This 510(k) summary describes a labeling change for the Straumann® Dental Implant System, not a new device or software with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this submission.

The "acceptance criteria" here refer to the regulatory acceptance of the proposed labeling changes, based on a clinical study and literature review supporting those changes.

Here's the breakdown of the information that is applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Purpose: To determine implant success and survival rates one year after implant placement, partly assessing the performance of Ø3.3 mm Roxolid implants in the molar region.
• Results: As of the 2-year time point in the molar region, there were two reported implant failures (one prior to restoration, one prior to 1-year mark post-restoration). No implant failure was reported after the 1-year follow-up in the molar region. Other adverse events included two cases of inflammation, one case of poor implant stability, and one case of peri-implant resorption. Most resolved.
• Conclusion: "This clinical data suggest that performance of Roxolid Ø3.3 mm implants placed in the molar region is equivalent to those placed in other parts of the mouth." This supports allowing the clinician to determine whether application in the molar region is appropriate for the particular patient. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (for the non-interventional clinical study subset): Not explicitly stated as a separate numerical value for the subset of data focusing on the molar region. The study "included subjects with the need of dental implant therapy and restoration according to the cleared indications for the Roxolid Ø3.3 mm implant."
• Data Provenance: Retrospective (post-market) non-interventional study in humans. Countries of origin include Germany, United Kingdom, France, Spain, Sweden, the United States, and Canada.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. The "ground truth" for this submission is based on clinical outcomes observed in a post-market study and a review of existing clinical literature by the manufacturer, rather than expert consensus on a specific test set.

4. Adjudication Method for the Test Set

• Not Applicable. This was a non-interventional clinical study where outcomes were observed and reported, not a study requiring adjudication of interpretations of data by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This submission is for a dental implant system, not an AI-powered diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This submission is for a dental implant system, not an algorithm.

7. The Type of Ground Truth Used

• For the clinical literature review: Published clinical evidence and consensus within the scientific community regarding metabolic bone diseases and dental implant outcomes.
• For the non-interventional clinical study: Observed clinical outcomes such as implant success, survival rates, changes in bone level, and adverse events, as documented by investigators.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this traditional 510(k) for a labeling change on a physical medical device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. See point 8.

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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 (Ø 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 Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) summary for the Straumann Dental Implant System. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory submission for a medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting performance data against predefined acceptance criteria for a new type of study or algorithm. This type of submission typically relies on existing standards, materials testing, and clinical history of the predicate devices.

Therefore, I cannot provide the requested information from the given text. The sections requested, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not present in this 510(k) summary.

Ask a specific question about this device

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). Strauman® 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 (Ø 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 Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

This document is a 510(k) summary for a medical device, the Straumann Dental Implant System. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML-driven solution.

The provided text describes a traditional medical device (dental implants) and its regulatory review process for substantial equivalence to a predicate device. It details the device's intended use, technological characteristics, and the FDA's clearance.

Therefore, I cannot provide the requested information, such as:

• Acceptance criteria table and device performance: Not applicable for this type of document.
• Sample size and data provenance for a test set: No test set is mentioned as this device is not an AI/ML product requiring such evaluation.
• Number and qualifications of experts for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study or human reader improvement with AI: Not applicable, as this is not an AI product.
• Standalone algorithm performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set and ground truth establishment for training set: Not applicable.

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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 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 in immediately loaded cases.

The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched. This surface has been modified for faster osseointegration and secondary stability. The dental implants are composed of Grade 4 titanium, cold worked. The neck of the implant is a smooth machined surface to allow for the attachment of epithelial tissue. Straumann implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths. No changes to overall implant design or dimensions were made.

The provided text is a 510(k) summary for the ITI Dental Implant System, specifically focusing on a modified surface (SLActive). The core of the submission is to demonstrate substantial equivalence to previously marketed ITI dental implants, primarily based on animal studies showing faster osseointegration and earlier secondary stability with the new surface.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for either test or training sets.

The document details the device description, intended use, and the basis for substantial equivalence, which revolves around animal studies comparing the SLActive surface to the SLA surface in terms of osseointegration and secondary stability. It states:

• "Increased bone to implant contact and earlier secondary stability with the modified surface compared to the SLA surface was demonstrated at early healing periods of 2-4 weeks in animal studies."

This means the study that 'proves' the device meets criteria (faster osseointegration and earlier stability) is an animal study. The acceptance criteria are implicitly those metrics related to bone-to-implant contact and stability measured in the animal study.

Therefore, for your specific request, I can only provide what is explicitly mentioned in the text.

Here's a summary of the information you requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Animal studies. The type of animal is not specified, nor is the country of origin. The studies are prospective in nature, comparing different implant surfaces.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not specified. The ground truth would likely be established through histological analysis and biomechanical testing from the animal studies, performed by veterinary pathologists or researchers. The text does not elaborate on this.

4. Adjudication Method for the Test Set

• Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret medical images. This submission is for a dental implant, and the evidence presented is from animal studies on osseointegration, not human interpretation.

6. Standalone (Algorithm Only) Performance Study

• No. This is not a software algorithm; it is a physical medical device (dental implant).

7. Type of Ground Truth Used

• Based on the description of "increased bone to implant contact and earlier secondary stability in animal studies," the ground truth likely involved:
  • Histology: Directly measuring bone-to-implant contact (BIC) from tissue sections.
  • Biomechanical testing: Measuring implant stability (e.g., resonance frequency analysis or push-out/torque removal tests).
  • Outcomes Data: In an animal model context, the "outcome" is the measured biological response of bone healing and implant integration.

8. Sample Size for the Training Set

• Not applicable as this is an animal study for a physical device, not an AI algorithm requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence based on pre-clinical (animal) studies of a physical device, not on clinical performance metrics or AI algorithm validation.

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