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Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. Compatible Implant Systems: | Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm | |---------------------------------------|---------------------------|---------------------| | Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini | | | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | | Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | | Nobel Active (Conical Connection) | 3.5 | NP | | | 4.3, 5.0 | RP | | | 5.5 | WP | | Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC | | | 4.1, 4.8 | RC | | Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | | | 5.0, 5.5, 6.5 | WB | All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm. All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table: | Implant Compatibility (1) | Minimum Wall Thickness, mm | Maximum Gingival Height, mm | Minimum Gingival Height (2), mm | Maximum Angulation | |---------------------------|---------------------------|----------------------------|--------------------------------|-------------------| | Osstem® TS Hiossen® ET (Internal Taper) | 0.32 | 5.18 | 1.2 | 25º | | Neodent GM (Morse taper) | 0.32 | 5.20 | 1.2 | 30º | | Nobel Active (Conical Connection) | 0.35 | 6.20 | 0.30 | 0º | | Straumann Bone Level (CrossFit® Morse Taper) | 0.32 | 5.18 | 1.1 | 30º | | Straumann BLX (TorcFit™ Internal Hexalobular) | 0.32 | 5.34 | 1.5 | 30º | (1) for the compatible sizes shown in Table 1 (2) minimum gingival height in the titanium base, not the zirconia superstructure The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609. Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. TRI Screws are intended to secure TRI-matrix® Crown Abutments to TRI-matrix® implants.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging designs for single-unit restorations. Dynamic TiBase abutments are provided in sizes compatible with the following SGS® Dental Implants System implants: SGS P1D, Conical connection, 5.0 mm body diameter, 3.5 (3.0 mm) platform; and SGS P7N, Narrow Conical connection, 3.2 mm body diameter, 2.1 (2.5 mm) platform. All Dynamic TiBase abutments are provided in a straight design (no angulation in the TiBase portion). All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. For the compatible SGS P1D Concal connection implant, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) of 0.5 mm, or 3.0 mm, and a prosthetic platform diameter of 4.3 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible SGS P1D Conical connection implant, the abutments have a prosthetic post height (length above the gingival height) of 4.0 mm, and a cut-out height of 2.5 mm. For the SGS P7N Narrow Conical connection implant, the gingival height (in the titanium base) is 0.5 mm or 1.5 mm. and a prosthetic platform diameter of 3.8 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible P7N Narrow Conical connection implant the abutments have a prosthetic post height (length above the gingival height) of 4.5 mm, and a cut-out height of 2.5 mm. Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration. The subject device TRI Screws are to be used only to attach TRI-matrix® Crown Abutments. The TRI-matrix® Crown Abutments and TRI-matrix® implants are manufactured by TRI Dental Implants Int. AG and were cleared in K203660. The TRI screws have a hexalobular instrument interface, a screw head diameter of 2.6 mm, 1-72 UNF thread, and an overall length of 5.15 mm or 7.6 mm. The TRI Screws are anodized to a gold color and are only intended to be used with straight abutments. The compatible abutments are made from zirconia and are for direct final restorations.

Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure. The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm. The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws. All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. The design parameters for the CAD-CAM zirconia superstructure for the Multi-Unit DAS System are: Minimum wall thickness - 0.25 mm Minimum post height for single-unit restorations - 4.0 mm Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants Minimum gingival height - 0.5 mm (in the Ti-Base) Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.

Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration. All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, a series of twopiece titanium base abutments that require the fabrication of patient-specific custom superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.