Product Description

Inclusive^® Universal Clearance-Limited Abutments (UCLAs) are indicated for laboratory use to manually create an implant-level custom abutment for a cement- or screw-retained restoration. UCLAs are precisely machined and attahed to the implant fixture (or implant analog) with a titanium screw of guide pin. The plastic sleeve on top of the abutment provides a supporting structure on which to wax the restoration. Each UCLA is specific to the restorative platform of the corresponding implant.

• Plastic UCLAs are used to create diagnostic wax-ups (try-in prostheses).
• These engaging UCLAs are indicated for single-unit resotrations to prevent rotation.

Accessories

Each Inclusive UCLA is packaged with a guide pin (Inclusive Guide Pin) and separate retaining screw (Inclusive Titanium Screw). The guide pin should be used during the fabrication process. The titanium screw is used while fitting the diagnostic wax-up, or for retaining a definitive restoration.

Contraindications

Contact between Inclusive Plastic UCLAs and soft tissue should not exceed a one (1) hour duration.

Angled abutments should not be used to restore small-diameter implants (less than or equal to 3.0 mm) in the posterior region.

Sterility

Inclusive UCLAs 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: 6.0

Material Composition: Polymers (acetal copolymer), Titanium alloy (Ti6Al4V)