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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.- validated milling center for manufacture.

The Abutment Mini Angled Morse 450 is intended for use with the S.I.N. Dental Implant System Zygomatic implants. S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K222231, K231127, and K170392.

This submission includes dental implants Epikut S with a Morse taper (MT) abutment interface and an acid-etched endosseous surface, and Epikut S Plus implants with an endosseous surface produced by acid- etching followed by application of a hydroxyapatite coating (HAnano) and the same described connection. The implant design and endosseous surfaces are nearly identical to the Epikut S and Epikut S Plus implants cleared in K222231, with the exception of the additional body/platform diameter (6.0 /5.2 mm) with lengths of 8.5, 10, 11.5, 13.

The subject device dental implants are summarized in the following table.

This submission includes Abutment Mini Angled Morse 45° in sizes from 1.5, 2.0, 2.5 with a 16° Morse taper connection mating abutments for screw retained, multi-unit prostheses and a prosthetic platform diameter of 4.8 mm, that is for exclusively use with cleared Zygomatic Plus implant. The corresponding abutment screw is PFMAAM 16A.

This submission includes Interface abutment MT 16° prosthetic components for fabrication of patient-specific abutments that are compatible with implants from S.I.N. Dental Implant System. Subject device Interface Abutments are two-piece abutments for which the second part (or top half) is the ceramic superstructure. The second part is designed and manufactured using CAD-CAM techniques. The titanium component of the Interface Abutments Morse Taper has a cementable platform diameter of 3.5mm, 4.5mm, or 5.5mm, cementable post-height of 4.0mm or 6.0mm, and a gingival height built into the titanium base component from 0.5mm to 4.0mm. The two pieces of the Ti-Base are bonded using Panavia Universal Dual-Cure Cement (K150704), as referenced in K190936. These abutments are used with a fixation screw PFMT 02A.

After scanning the intraoral area, the S.I.N.-validated milling center will receive the STL file and design the coping/superstructure using computer software (CAD) according to the design parameters below and the space available.

Design parameters for all Interface CAD-CAM Abutments superstructure are:

• Minimum wall thickness – 0.5 mm
• Minimum abutment post height for single-unit restoration – 4.0 mm
• Maximum angle – 0°. Straight only
• Maximum gingival height – 5.0 mm
• Minimum Gingival height – 0 mm
• Maximum allowable abutment Post Height – 6 mm
• Total abutment height – 10mm
• Abutment diameter – depends on available space (for the patient)

By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.

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