NISO - DENTAL IMPLANT SYSTEMS

Trade Agreement: WTO-AGP/NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama Tendering Procedures: Generally only one firm has been invited to bid Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: Nobel Biocare Canada Inc. 9133 Leslie St. Unit 100 Richmond Hill Ontario Canada L4B4N1 Nature of Requirements:

DENTAL IMPLANT SYSTEMS

1. Advance Contract Award Notice (ACAN)

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.

2. Definition of the requirement

The Department of National Defence (DND) has a requirement for a National Individual Standing Offer on an ?as and when? requested basis for the supply of Dental Implant Systems, products, instruments and accessories for the use in the installation, repair and refurbishment of existing Dental Implants. Delivery will be made to various DND Dental Units across Canada.

3. Criteria for assessment of the Statement of Capabilities

Any interested supplier must demonstrate by way of a statement of capabilities that its product meets the following requirements:

MANDATORY SPECIFICATIONS FOR DENTAL IMPLANT SYSTEMS

1.0 General Description

2.1 This package describes essential characteristics of a dental implant system, implants diagnostic/treatment/placement software and accessories.

2.1.1 The product/products offered must be licensed for sale in Canada andmeet all applicable Health Canada Standards.

2.1.2 Products offered must be of proven design and an industry recognized brand with institutional users (Governments, Universities, or Hospitals), and with demonstrated customer support for a minimum of5 years.

2.1.3 All components making up the equipment systems and diagnostic/treatment/placement software must be from the same manufacturer to ensure interoperability and compatibility.

IMPLANT DIAMETERS

3.1 The diameter must be measured at the abutment interface. The implants must have as a minimum 3 different size categories typically referred to as Narrow, Regular, and Wide platform:

a. Narrow 3.0 mm to 3.5 mm

b. Regular 3.4 to 4.0 mm and 4.3mm

c. Wide 4.5mm to 6.0mm, and

d. Zygomatic Implants of all lengths 4.0 (RP).

4.1 IMPLANT LENGTHS

The implants must have at a minimum 5 different conventional implant lengths ranging, as a minimum, from the shortest 8mm to the longest 18mm, along with implants of a length appropriate for zygomatic placement (30 to 52.5mm).

5.0 CONNECTIONS

The implants must have both external and internal connectivity and the orientation must be reproducible.

6.0 PLATFORM SWITCHING OR SHIFTING

Defined as reduced diameter size for the abutment relative to that of the implant, at their interface.

7.0 IMMEDIATE IMPLANT PLACEMENT

Implant design must provide adequate initial stabilization in anterior and posterior extraction sites immediately post extraction forimmediate loading.

8.0 ABUTMENT PLACEMENT

The implant system must allow for staged (delayed) and immediate abutment placement.

9.0 MICRO AND MACRO SURFACE TEXTURING

9.1 The implant macroscopic surface must be the screw type. Cylinder macroscopic surface implants are unacceptable. There must be the option for self-taping.

9.2 The microscope surface texturing may include but is not restricted to titanium plasma spray, acid etched, or blasted.

10.0 SURGICAL IMPLANT KIT

10.1 All surgical instrumentation required to perform osteotomy and to place implant must include at a minimum but not be limited to:

a. initiating drill (both round and pointed),

b. pilot drill (approx 2 mm in diameter),

c. subsequent drills for corresponding implants diameters,

d. dense bone drill,

e. counter-sink,

f. all necessary drivers,

g. bone tap,

h. direction indicator (aka paralleling tool) ,

i. manual torque wrench,

j. surgical driver (manual manipulation for final implant orientation),

k. tissue punch,

l. drill extensions, and;

m. depth guide.

10.2 The drill depth marking must be visibly conspicuous throughout the surgical procedure and must be laid out in a color matching drill sequence that corresponds to theappropriate implant size.

10.3 Surgical instrumentation must have bone level and tissue level implants.

10.4 Surgical instrumentation must have osteotomes that match the surgical drills

10.5 Surgical instrumentation must have tapered and straight implant shapes.

11.0 PROSTHETIC IMPLANT KIT

11.1 All prosthetic instrumentation must include, but not be limited to

a. impression making,

b. healing abutment/cap removal, and;

c. final abutment placement.

11.2 All prosthetic implant kit components must have a corresponding color scheme consistent with implant and surgical components. As a minimum, the kit must include:

a. varying length drivers for torque wrench and screw-drivers;

b. manual torque wrench; and;

c. sterilizable, easy to use organizer (box).

12.0 CASTABLE ABUTMENTS

12.1 The castable abutments must have an abutment that enables modification through casting to develop a screw retained abutment and/or crown.

13.0 SELECTION OF OVERDENTURE ATTACHMENTS

13.1 At a minimum there must be a ball-type attachment and a locator-type attachment.

14.0 MILLED ABUTMENTS, TITANIUM AND ZIRCONIUM

14.1 The milled abutments, titanium and zirconium must have a selection of abutments that includes as a minimum: 2 or more angles for angled abutments of approx: 15 degree and 25 degrees.

14.2 The milled abutments, titanium and zirconium must have screw and cement retained abutments.

15.0 CLOSED TRAY AND OPEN TRAY IMPRESSION TECHNIQUES

15.1 The closed tray and open tray impression techniques must have implant level impression copings that can be screwed into place and have surface features that are well enough defined to ensure 100% accuracy in reinserting elastomeric impression material once the impression is removed for open tray and closed tray techniques.

15.2 The closed tray impression coping must have a height range from approx 8-10 millimetres.

15.3 The closed tray impression coping must have selected abutment level impression coping for at least one abutment system.

16.0. IMPLANT, COMPONENT, AND IMPLANT SYSTEM AVAILABILITY

16.1 The implants, implant systems, instruments and accessories must be available to the CFDS for a minimum of 10 years after contract award.

17.0 TEMPORARY ABUTMENT SYSTEM

17.1 As a minimum, the temporary abutment system must allow temporization of single units and multiple units.

17.2 A temporization system for a screw retained temporary crown and cementable temporary crown must be available as an option.

18.0 IMMEDIATE FUNCTIONAL FULL ARCH ON 4 (FOUR) IMPLANTS CONCEPT

18.1 The implant system must have surgical and prosthetic components and the ability to use four implants per arch to support an immediately loaded full arch prosthesis.

19.0 MEDICAL DEVICES AND ESTABLISHMENT LICENSES

19.1 The products offered must be licensed for sale in Canada and meet all applicable Health Canada standards.

19.2 The company manufacturing the implants, the implant system and accessories must supply a copy of a valid and current Health Canada Medical Devices Class III (medical devices) license. Further, importers and/or distributors must supply a copy of a valid and current Health Canada issued Establishment License (EL). Certificates and or licenses referenced in para 19.2 above must be current and valid at the date/time of bid closing.

19.3 To ensure compatibility and implant systems and accessories integrity all equipment components or systems must be provided from the same manufacturer.

20.0 DIAGNOSTIC/TREATMENT/PLACEMENT/SOFTWARE

20.1 Diagnostic treatment planning software must assure a predictable outcome.

20.2. Diagnostic treatment planning software must accept 3D imagery and produce surgical templates.

20.3. Diagnostic treatment planning software must conform/be compatible with Department of National Defence information technology security requirements, and patient confidentiality regulations and procedures.

20.4 Diagnostic treatment planning software must be provided all updates free of charge for the duration of the Standing Offer Agreement.

4. Applicability of the trade agreement(s) to the procurement

This procurement is subject to the following trade agreement(s)

Agreement on Internal Trade (AIT) NorthAmerican Free Trade Agreement (NAFTA) World Trade Organization - Agreement on Government Procurement (WTO-AGP)

5. Justification for the Pre-Identified Supplier

The only known supplier of Dental Implant meeting all the above required technical specifications is Nobel Biocare. For this reason, it is proposed to negotiate this requirement with Nobel Biocare.

6. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under the

Agreement on Internal Trade (AIT) - Article 506.12(b) North American Free Trade Agreement (NAFTA) - Article 1016.2(b) World Trade Organization - Agreement on Government Procurement (WTO-AGP) - Article(s) Article XV (b)

7. Period of the proposed Standing Offer

The proposed period for making call-ups against the Standing Offer is three (3) years with an option to extend for two (2) additional one (1) year periods.

8. Name and address of the pre-identified supplier

Nobel Biocare Canada Inc. 9133 Leslie St. Unit 100 Richmond Hill, Ontario L4B4N1 Canada

9. Suppliers' right to submit a statement of capabilities

Suppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

10. Closing date for a submission of a statement of capabilities

The closing date and time for accepting statements of capabilities is March 18, 2016 at 2:00 p.m. EDT.

11.Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to

Martin Gauthier Supply Officer Public Works and Government Services Canada Scientific, Medical and Photographic Division - PV Portage III - Floor: 6A2 - Room: 48 11 Laurier Street Gatineau, Quebec Canada K1A 0S5

Telephone: 613-404-8642 Facsimile: 819-956-3814 E-mail: martin.gauthier@pwgsc.gc.ca

Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.