JA_Abutments_III_Redacted.pdf

LOG # 16-10117

Form 02.4G.AB / N3251016RQD3012 Page 1 of 3 16 Dec 2015

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Naval Medical Center Portsmouth, Virginia 23708.

2. Nature and/or description of the action.

The requirement is for dental implant abutments for Naval Medical Center Branch Health Clinic Norfolk, Virginia. The Government intends on awarding a Firm Fixed Price Indefinite Delivery Indefinite

Quantity contract. The proposed source is Dentsply IH, Inc., 590 Lincoln St., Waltham, MA 02451-2173.

3. Description of the supplies/services required.

The requirement is for dental implant abutments. The contractor shall be able to provide dental implant abutments as required for dental patients at Naval Medical Center Branch Health Clinic Norfolk.

The contractor shall be able to provide dental implant abutments as needed for patient care. The vendor shall provide the following dental implant abutments on an as needed basis:

a. Titanium Implant Abutment

b. Titanium Gold Shaded Abutment

c. Zirconia Abutment

d. Titanium Duplicate Abutment

e. Zirconia Shaded Abutment

In recent years the Navy has seen an influx of patients with dental implants made by a variety of manufacturers (this is due to individuals receiving dental services outside the military environment). As the types of implants in patients expand to cover a multitude of implant manufacturers, the need exists for the Navy to provide implant abutments for a wide variety of implant systems. The subsequent need to provide abutments for an expanding list of implant types is made difficult since each manufacturer requires specific equipment and additional parts for their own implant systems. Since each manufacturer makes their own abutments, manufactures will not warranty their abutments to other manufacturer implants. While some companies provide compatible abutments covering a limited number of manufacturer implants, the end user is required to possess the specific equipment, additional parts and the addition of a laboratory technician to wax the shape of an abutment before scanning. Additionally, these companies will not warranty the implant that the abutment was created for.

The contractor shall design the abutment according to a set of rules and handle the complexity of abutment design without the need for a technician to manually create a model. It shall involve digital duplication with a computer aided manufacturing processes to create precision machine abutments for customization to the widest range of implant systems. The system shall measure the oral geometry of a patient’s mouth.

The contractor shall have the technology coupled with their computer aided manufacturing process for abutments to customize abutments without regard to the implant manufacturer. In addition to manufacturing a wide variety of implant systems the contractor will warrant not only their abutment but the implant replacement cost if the implant fails while using their abutment.

The contractor shall deliver manufactured products to the site with a maximum turn-around time of 10 days from the date the order is received.

The Government shall be responsible for all shipping costs, including shipment of physical cases from the

Form 02.4G.AB / N3251016RQD3012 Page 2 of 3 16 Dec 2015 dental laboratory and the contractor shall be responsible for all return shipping costs.

The contractor shall provide a digital receipt to the submitting laboratory for all case submissions. The contractor shall notify the submitting laboratory of any observed design or manufacturing problems within two (2) hours of case submission.

If a product is delivered to the site that does not meet the requirement of the government, the contractor shall correct the deficiency, remanufacture another product, and deliver to the site with no additional cost to the government with a maximum turn-around time of 10 days.

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.

Defense Health Program Operations & Maintenance (DHP O&M) (FY16) funds in the amount of will be used to fund the requirement. An additional in options will be exercised if funding is approved for a grand total of .

Base Year Option Year

Option Year

Option Year

Option Year

Total

4. Identification of the statutory exceptions 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 Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996).

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

Dentsply IH, Inc. has the ability to computer generate a milled titanium, gold hue and zirconia implant abutments compatible with both the BIOMET 3i and the Nobel Biocare System used by Navy Providers.

In addition, Dentsply IH, Inc. has the ability to fabricate the full zirconia abutments and the BIOMET 3i

6.0 size titanium or gold hue abutments requested by Navy Providers. No vendor other than Dentsply IH, Inc. can provide dental implant abutments that meet the minimum requirements of the Government.

In order to service the Navy utilizing any other contractor other than Dentsply IH, Inc. would require contracts with individual manufacturers. Some manufacturers require specific equipment for their abutment fabrication. The Navy standard system currently used is Nobel Biocare and BIOMET 3i.

Currently, Dentsply IH, Inc. remains the only known source capable of meeting the Navy’s minimum needs.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted

Form 02.4G.AB / N3251016RQD3012 Page 3 of 3 16 Dec 2015 to FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

7. 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. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in August 2015 including a search of the Internet using Google, GSA

Advantage and a VA MedSurg Catalog Search. Other dental implant CAD/CAM vendors include New

Image Dental Lab, BIOMET 3i, Dominion Milling Center, and Biohorizons Implant Systems Inc.

New Image Dental Lab cannot meet the minimum requirements of the government because they do not have the ability to computer generate a milled titanium, gold hue or zirconia implant abutments compatible with both the BIOMET 3i and the Nobel Biocare System used at this command.

BIOMET 3i cannot meet the minimum requirements of the government because they offer an abutment product for the BIOMET 3i system but for the Nobel Biocare System they require additional equipment to be purchased ($50,000 Scanner) and a laboratory technician to wax the shape of the Nobel Biocare abutment before scanning and sending to this company. No abutment screw is included in the cost of the scanned abutment. They also use an encoded healing abutment with the fabrication of their abutment. In addition they require the purchase of the encoded abutment for each implant that is placed resulting in a significant cost based on volume of implants placed at this and other facilities.

Dominion Milling Center cannot meet the minimum requirements because they do not fabricate the full

Zirconia Abutments and or the BIOMET 3i 6.0 size titanium or gold hue abutments requested by Navy

Providers. Biohorizons Implant Systems cannot meet the minimum requirements of the government because they just sell the implant parts and do not mill the implant abutments for the providers. These four vendors do not meet the needs of the government. Dentsply has the ability to fabricate the milled titanium, gold hue and full zirconia abutments for both the Nobel Biocare System and BIOMET 3i systems used by Navy Providers. No vendor other than Dentsply IH, Inc. can provide dental implant abutments that meet the minimum requirements of the Government.

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

None

10. Listing of Sources, if any, which 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. Statement of 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.

12. Point of Contact

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is , who may be reached at