SOW-Dental-Sirona CAD CAM System.docx

Purpose CEREC Dental CAD/CAM System provides technological precision, superior design, and excellent performance. It acquires precise digital impressions with CEREC Primescan, designs the proposal on the Primescan using the intelligent software, then produce precise, smooth restorations with CEREC Primemill milling unit. With CEREC Speedfire, it can produce and sinter full-contour zirconia in a single visit. Fixed Dentistry involves crowns and bridges. It is a Level of Care V type of dental procedure, complex rehabilitative.

Definitions Fixed prosthodontics are individual crowns, bridges (retainers and pontics), and abutments/above the gingiva superstructure. Dental implants are placed in bone to provide an immobile structure for above gum restorations.

Policy The dental department will utilize the Dentsply Sirona CAD/CAM equipment to make many patient-specific solution for design and material processing. Digital impressions of crowns and bridges preparation will be taken with Primescan. The milling unit will enable dental professionals to manufacture restoration of excellent quality onsite and same day in the dental clinic.

Procedures

1. The Sirona Dental CAD/CAM System is an optical impression system for computer assisted design and manufacturing (CAD/CAM) according to 21 CFR 872.3661. The system records the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-assisted design and manufacturing of dental restorative

2. The workflow is illustrated in the Sirona Software in 5 phases:

A. Administration B. Scan C. Model D. Design E. Produce

3. In the Administration phase, the operator creates restoration and determines their type, Specify a production machine, and select material.

4. In the Scan phase, the operator performs the acquisition with inEoS X5/Blue scanner of the lower jaw, upper jaw, and buccal registration. View a 3D preview of the acquisition, add additional image catalogs, and import STL scan data.

5. In the Model Phase, the operator edits the model. Check or redefine the bite situation, Align the models. Check the trimmed model or manually re-trim. Check, correct or re-enter the preparation margin. Define insertion axes. Define jawline and restoration positions. Define restoration axes if necessary (abutments and telescopes only). Select the patient photo for Smile Design (if needed).

6. In the Design Phase, the operator select tooth form. Position and scale restorations. Individually change restoration parameters. Have initial restoration suggestions generated. Design restorations individually.

7. In the Production Phase, the operator specify a production machine. Define manufacturing option (not possible for all materials). Determine the block size. Check and adapt the positioning of the restoration in the block. Define the sprue location of the restoration. Start the manufacturing process. Export the restoration / model for the inLab CAM SW or as *.stl files.

8. Traditional crown and bridge dentistry will still be acceptable if fabricated from poly vinyl or poly ether or similar impression materials, however

9. All materials will become property of the U.S. government.

Minimum Performance Requirements A. Fixed Prosthodontics

1. CEREC Dental CAD/CAM System provides the “Articulation function” which enables the operator to configure a restoration taking the dynamics into consideration.

2. To ensure proper form and function, the operator is able to use the virtual articulator to verify various dynamic contact points via laterotrusion, mediotrusion, protrusion, centric, latero-protrusion.

3. The lower jaw on the virtual articulator can be moved manually in accordance with the calculated masticatory movement using the “Manual Move” button.

Patient selection criteria include

a. Patients presenting to the FYHC Dental Program requesting a dental prosthesis must have a current comprehensive dental exam and treatment plan by a FYSU dental officer. The dental treatment plan must be completed prior to the fabrication of the dental prosthesis.

b. Patients requesting a dental prosthesis must be Service Unit Patients and reside within the Service Unit boundaries as defined by the FYHC. They must be CHS-Direct eligible.

c. Patients requesting a dental prosthesis should support the IPC model and should be empaneled to a FYSU primary care provider. The patient should have 2 current primary care provider visits on record addressing current or chronic conditions of the patient.

d. Preference will be given to medically compromised patients presenting with a need for a dental prosthesis. Medically compromised conditions include patients with diabetes, hypertension, weight loss due to inability to masticate food and severe, aggressive periodontitis or caries of the oral cavity.

e. Patients must comply with the Dental Program Broken Appointment Policy. The policy states "BROKEN APPOINTMENTS are when a patient is over 15 minutes late for their appointment. When a patient breaks an appointment, they may be required to procure another appointment from the dental front desk. If the patient breaks 2 such appointments in a 6 month period, they may be required to receive treatment on a walk-in/emergency basis only for the following 6 months. This can allow the dental clinic to maintain available appointments for patients who can predictably arrive to their appointments."

f. Dental prostheses will be fabricated, fit and delivered only once in a 5 (five) year period.

Lost or broken prostheses will not be replaced using FYSU funding and will be evaluated on a case by case basis.

10. The CEREC Dental CAD/CAM System Calibration can by performed by operator when the inLab SW is switch on. The jaw model supplied for calibration is ready. Position the calibration model on the rotation disk in such a way that the front teeth are facing directly in the direction of the unit. Additionally, the milling unit can also be calibrated by click on the “Calibrate” button the simply proceed as prompted by the software.

Section 508 and Accessibility

1. This product must conform to the Revised Section 508 (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines) and WCAG 2.1 Level AA standards as outlined below.

1. Solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template. The template can be found at https://www.itic.org/policy/accessibility/vpat.

All Information and Communication Technology (ICT) deliverables under this contract (e.g., websites, applications, electronic documents, and multimedia) must comply with the Revised Section 508 Standards (36 CFR Part 1194) and the Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards. The Contractor shall ensure accessibility of all ICT deliverables and provide conformance documentation in the form of a Voluntary Product Accessibility Template (VPAT®) / Accessibility Conformance Report (ACR), or by completing the HHS Section 508 Accessibility Checklists. The current VPAT 2.5 template includes fields for reporting conformance to WCAG 2.1 and shall be used to document accessibility. The Contractor shall remediate any identified accessibility issues at no additional cost. The Contracting Officer will include the applicable Health and Human Services Acquisition Regulation (HHSAR) clauses 352.239-73 and 352.239-74 in the solicitation and resulting contract.