PANHCA-25-P-0000_006781 Limiting Competition_FINAL_Redacted.pdf

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Dental Diode Laser
Solicitation number
W81K00-25-Q-A054
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This is a Memorandum for Record (MFR) documenting a sole-source procurement for a Dental Diode Laser for William Beaumont Army Medical Center's Dental Clinic 3. The Medical Readiness Contracting Office - West is seeking to purchase the SIROLaser Blue from Dentsply Sirona, a large business, for $24,096.00 using Operations & Maintenance Army (OMA) funds in fiscal year 2025. The procurement is justified because the SIROLaser Blue is the only diode laser on the market offering functionality at three different wavelengths (445nm, 660nm, and 970nm), which provides unique clinical capabilities for soft tissue management, wound healing, and periodontal treatments.

Market research confirmed that only Dentsply can meet the specific requirements, with no small businesses capable of providing the laser. Two authorized distributors were identified (Henry Schein and Patterson Dental Supply), and market research revealed that other potential vendors like BIOLASE and Ultradent could not meet the detailed specifications. The laser's unique features include being the first FDA-cleared Blue Laser for dental use, offering no-contact cutting, improved hemostasis, and enhanced efficiency for various dental procedures, particularly in managing soft tissue and periodontal treatments.

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Control No: 25-MRCO-WEST-106

Version – February 2017

MEMORANDUM FOR RECORD

Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office – West

2. Description of Action: Dental Diode Laser

Nature: XX New Requirement Follow-on Requirement

Contract Vehicle: XX Purchase Order Number PR 0012252653_________ Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract Name or #______________

Order #_______ against a single award IDC Contract Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: XX Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) XX Other Funds: _ DHP__

FY: 2025

Name of Proposed Contractor(s) and Address:

Name UEI Business Size/Type

Dentsply Sirona Charlotte, NC

JKNSTU7338Q9 Large Business

Henry Schein In.

Melville, NY

D6MTSKS115L9 Large Business

Patterson Dental Supply, Inc.

Saint Paul, MN

WZZFUJMEQN14 Large Business

Brand Name Buy: XX Yes No

3. Description of Services or Supplies: Dental Diode Laser that offers an alternative treatment option for scalpel surgery and the electro surge for soft tissue management during prosthodontic treatment.

Total Value: $ 24,096.00

4. Authority:

XX FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: The SIROLaser Blue, Part Number 6654227, is the only diode laser on the market that offers functionality at 3 different wavelengths, 445nm, 660mn, and 970nm. This allows for more versatile usage, as outlined below

The 445nm wavelength is what makes this diode laser unique compared to others on the market. This is the first FDA-cleared Blue Laser for dental use. The 445nm wavelength absorbs more efficiently in soft tissue which results in improved soft tissue cutting efficiency and allows for no-contact cutting. With no-contact cutting, there’s no need to remove hemoglobin, the hemostatic effect is outstanding, thus helping with all surgical treatments and improving prosthetic workflow.

The 660nm wavelength is an excellent adjunctive for surgical and therapeutic procedures. It offers improved wound healing and tissue regeneration, which can significantly improve results from periodontal surgeries and prosthodontic procedures. It also results in reduction of acute and chronic pain through increased localized blood circulation allowing for temporary relief of minor muscle and joint pain, frequently seen in our patient population.

The 970nm wavelength will be used for periodontal disease as an adjunct to scaling and root planning procedures. Currently, both in civilian and military practice, access to hygiene care has been a challenge. In our clinic, access to care for scaling and root planning is over 90 days. With this laser, providers can be more efficient with treatment of periodontal patients and will allow for a more optimized hygiene workflow than our current methods.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 XX do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at

5.202 ______________________.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $250K, no posting required XX Action is a brand name restriction, under $25K, no posting required. If this purchase exceeds $25k, it will be redacted and posted to SAM, accordingly.

Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C)

FAR 16.505(a)(4)(iii(C)

7. Market Research: Market research was completed in accordance with applicable FAR 10.002(b) (2) procedures. Market Research was conducted in January and February 2025. The research resulted in two open market sources that are large businesses, BIOLASE and Ultradent, that could not meet the requirement specifications (e.g., lasers with only one wavelength).

Dentsply, which is a large business is able to provide a product that meets the clinical and requirement specifications. There are no small businesses that are able to provide a quote for the dental diode laser. A Request for Information (RFI) RFQ#1742253 using SIN 6511A/A-39 was submitted through GSA Advantage, FSS/VA schedule holders, resulting in no bids. Information from various internet sites and industry associations were included in developing the market research.

A search of the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) was conducted using 339114 and keywords Laser, Diode, Dental. The results show that there are no small businesses that may be able to provide these materials. A further review of economic groups under this NAICS is found in Table 1, DSBS Summary located within the market research report. A broader review of the DSBS database using NAICS 339114 and keywords Laser, Diode, Dental results returned no small businesses that may be able to provide this system.

A review of a variety of Federal Supply Schedules was conducted, however neither were able to meet the requirement. An on-line review of the marketplace indicates the SIROLaser Blue from Dentsply meets the requirements of Dental Clinic 3 (DC3).

8. Other Facts: On 03/06/2025, the Contract Specialist spoke with Dentsply Sirona, the manufacturer of the required equipment, to confirm its distribution network. Dentsply informed the specialist that, while it has many other authorized vendors, only two are authorized to sell this equipment. These companies include Henry Schein and Patterson Dental.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date:

Title:

Signature:

10. Contracting Officer Certification/Approval: This certification should be made by the Contracting Officer who will sign the contract resulting from this justification memorandum.

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon (describe technique to be used, e.g. price analysis, cost analysis, etc.).

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date:

Title: Contracting Officer

Signature:

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