Statement_of_Requirements.docx

1. Prepare dental fixed, removable and implant dental laboratory cases on a case by case basis as required by the Naval Branch Health Clinics.

2. The contractor shall send cases by FEDEX at the government expense or personally deliver at contractor’s expense. The contractor is responsible for completing the requested procedures and returning the completed case work NLT than 10 business days from the date received by the contractor.

3. The contractor shall guarantees all work to be completed to the satisfaction of the ordering dentists. The contractor will provide a single point of contact responsible for taking customer complaints, changes and problem resolution.

4. DD Form 2322 will be forwarded to the vendor immediately following the placement of a delivery order. Direct delivery will be made to the facilities listed below. Maximum turn-around time of 10 days from the date the order is received.

5. Work is warranted against manufacturer’s defects for a period of no less than 6 months. The Warranty is to provide no cost parts, labor, travel and shipment of parts.

-The Bellatek Copymilled Bars, Bellatek Primary Bars, Hader, Hybrid and Encode abutment must be a one piece milled titanium alloy structure with a passive fit.

-The laboratory will outsource the soft tissue master cast to the outsource lab who will design and mill the appliance.

-The appliance will be polished and ready for the overdenture processing or the addition of porcelain or acrylic resin with minimal finishing required by the laboratory.

- The lab shall create their unique framework design with a resin pattern and outsource with the soft tissue master cast to be scanned and milled.

-The lab may create their unique framework design with a resin pattern and outsource with the soft tissue master cast to be scanned and milled for the Copymilled bar.

-The copymilled framework shall be available in Cobalt Chrome alloy and Titanium.

-The appliance shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.

- Vendor shall be an Original Device Manufacturer authorized dealer, authorized distributor or authorized reseller for the proposed device, warranty and service are provided and maintained.

The outsourced lab must provide Dental Office Handling Guidelines for disinfecting appliances:

1. Steam sterilization protocols for gravity displacement and dynamic air removal cycles that comply with ANSI/AAMI ST79 recommendations.

2. Dry heat sterilization protocols that comply with ANSI/AAMI ST40 recommendations.

Further, the device must have documentation of FDA approval for patient care.

3. Intermediate level disinfection is also recommended.