Product Description

Inclusive^® Titanium Abutment Blanks are designed to be used for the production of custom titanium abutments. All digitally designed abutments are intended to be sent to a Prismatik Dentalcraft-validated milling center for manufacture.

Accessories

None

Contraindications

Inclusive^® Titanium Abutment Blanks should only be used for the application described.

The following conditions would contraindicate use of Inclusive Titanium Abutment Blanks:

• Wall thickness less than 0.5 mm
• Gingival margin diameter less than 0.5 mm wider than the implant
• Angle corrections of more than 30 degrees
• Less than 0.5 mm margin height
• Less than 4.0 mm post height

Hybrid abutments (zirconia abutments with titanium base) are contraindicated by the conditions listed above, and in cases with angle correction or gingival height greater than 6 mm. A patient-specific finished device will consist of both the titanium base and zirconia coping.

Sterility

Inclusive^® Titanium Abutment Blanks are shipped NON-STERILE. Non-sterile items must be cleaned, disinfected, and sterilized prior to clinical use, according to a validated method.

• Cleaning: Wash using a broad spectrum cleaning solution, followed by thorough rinsing and drying.

The recommended disinfection process is based on ANSI/AAMI ST79 guidelines, as follows:

• Disinfection: Immerse abutments in disinfectant¹, rinse with distilled water and dry.

The recommended sterilization process is based on the ANSI/AAMI/ISO 17665-1 and ANSI/AAMI ST79 guidelines, as follows:

• Sterilization: Gravity-fed sterilizers: Autoclave in sterilization pouch for 15 minutes at 132^°C (270^°F). Allow sterilized components to dry for at least 30 minutes.

NOTE: The validated procedures require the use of FDA-cleared sterilization trays, wraps, biological indicators, chemical indicators, and other sterilization accessories labeled for the sterilization cycle recommended. The healthcare facility should monitor the sterilizer for the facility according to an FDA-recognized sterility assurance standard such as ANSI/AAMI ST79.

¹Oral disinfectant containing Chlorhexidine is recommended; refer to the disinfectant manufacturer's instructions.

Technical Specifications

Platform: RN synOcta

Material Composition: Titanium alloy (Ti6Al4V)