J A_CAD_CAM_Redacted.pdf

Log # 16-10254

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Naval Postgraduate Dental School, Naval Medical Center San Diego (Area Dental Lab), and Norfolk Area Dental Laboratory.

2. Nature and/or description of the action being approved.

The requirement is for dental prosthesis computer-aided design/manufacturing systems. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Imagine Milling Technologies, 14225 Sullyfield Cir, Chantilly VA 20151.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The system shall include a dental prosthesis computer-aided design/manufacturing (CAD/CAM) unit.

The system shall include a dental contact scanner and a dental light scanner. The contact scanner shall be able to capture positional data and angulation data for dental implants. The contact scanner shall have an accuracy of at least 20 microns. The contact scanner shall be capable of scanning for multi-unit implant frameworks. The system shall include a scanner that can simultaneously scan upper arch, lower arch and die. The light scanner shall be able to quickly scan multi-unit implant frameworks and create 3-dimensional digital images. The light scanner shall also be capable of impression scanning. The light scanner shall be able to scan full size articulators. The light scanner shall use calibrated articulator scanning. The light scanner shall utilize a static scan table that does not require rotation or inversion, yet allow for cast removal during the scan process without disrupting the scan workflow.

The system shall include CAD software capable of collecting data from the contact and light scanners.

The software shall be able to integrate the data sets from the contact and light scanners into one digital implant model.

The system shall include dental implant milling units. The milling units shall be capable of dry and wet milling. The milling units shall be capable of milling via 5 axes. The milling units shall be able to mill all dental implant materials, including titanium, cobalt chromium (CoCr), zirconium oxide, aluminum oxide, glass ceramics, Poly(methyl methacrylate) (PMMA) and resins. The system shall include milling units that are capable of milling IPS e.max restorations, specifically up to 48 restorations in single production cycle. The milling units shall be capable of automatically switching diamond and carbide milling tools for up to 32 tools. The milling units shall utilize collet chucks to hold the milling tools. The milling unit shall be able to wet mill glass ceramics, titanium and CoCr. The milling unit shall include a starter set of milling tools. The system shall include one (1) dental milling unit that has the capability of modulating the interior performance temperature based on the outside ambient temperature of the dental lab. The milling units shall be compatible with the existing CAM milling strategies utilized at the Naval Area

Dental Laboratories.

The system shall include an open source solution that allows for data to be transmitted between all subcomponents. The system shall include all necessary software for transferring images from acquisition scanning units to the milling units. The system software shall allow for output of implant interfaces in designed restorations. The system shall be able to provide and apply manufacturing protocols for dental implants including crowns, bridges, copings, abutments, abutment bars, inlays and onlays. The system shall have a preloaded template library of common dental implants connections including, but not limited to: standard and external hex; 3.25mm, 3.4mm, 4.1mm, 4.3mm, 5.0mm,and 6.0mm; engaging and non-engaging.

The system shall be capable of designing and manufacturing multiple-implant prostheses. The system shall be capable of manufacturing multiple-implant prostheses with a tolerance no more than 20 microns.

These tolerances must be acceptable for the 20 different implant connections utilized by the government.

The requirement includes three-dimensional dental printers for producing dental models. The printers shall be able to produce orthodontic models, partials, surgical guides, and bite guards. The printers shall be able to utilize build plates ranging from 3.75” x 3.75” x 2” to 10.5” x 6.5” x 3”. The printers shall be able to produce models of the entire array of teeth (jaw). The printers shall be able to produce models that include analog implant insertions. The printers shall print at a resolution of at least 50 µm.

The requirement includes installation, calibration, and on-site training.

The equipment 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. The equipment shall be installed in compliance with OSHA requirements.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Navy 2014 OP funds in the amount of will be used to procure the equipment. The total contract award, inclusive of all unexercised options, is .

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1) and FAR 13.501(a), Sole Source (including brand name) Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 (section 4202 of the Clinger-Cohen

Act of 1996).

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Imagine Milling is the only vendor capable of meeting the minimum requirements of the government.

Imagine Milling is the only vendor capable of providing an open source system with integrated contact and light scanners. The system provided by Imagine Milling is the only system that incorporates both a contact and light scanning acquisition unit that can transmit data collaboratively to the milling unit.

Contact scanning is required to meet the accuracy requirements of multiple-implant prostheses. Light scanning alone is capable of measuring multiple-implant prostheses, but it does not provide the required accuracy associated with contact scanning. Imagine Milling is the only vendor capable of providing a solution that can integrate and merge the data from the contact and light scanner into a single digital implant model. Imagine Milling is the only vendor capable of providing a light scanner that can use a calibrated articulator approach that can scan full size articulators. No vendor besides Imagine Milling can provide a system compatible with the existing CAM milling strategies utilized at the Navy Area Dental

Laboratories. No other vendor, besides Imagine Milling, can provide a system that meets all of the minimum requirements of the government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart

5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted in June-July 2016 including a search of the Internet using Google, GSA

Advantage, the ECRI Sourcebook, and service inventories. Other laboratory dental implant CAD/CAM manufacturers include Custom Automated Prosthetics, Origin CADCAM, DAL DT Technologies, and

Broadway Dental. Products from these vendors do not meet the minimum requirements of the

Government because they do not offer an integrated contact scanner. Renishaw is the only manufacturer of a contact dental scanner and Imagine Milling is the only US distributor of Renishaw products. No vendor other than Imagine Milling can provide a system with hardware and software that can integrate and merge data from a light and contact scanner into a single digital implant model. No vendor other than

Imagine Milling can provide a system that meets the minimum requirements of the Government.

9. Any other facts supporting the use of other than full and open competition.

None

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.