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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.