DECLARATION OF NOLAN KNIGHT
`
`I, Nolan Knight, affirm and declare as follows:
`
`1.
`
`I am the Engineering Manager at Knight Mechanical Testing, LLC
`
`("KMT"), an ISO/IEC 17025:2005 accredited independent mechanical testing
`
`laboratory located in Fort Wayne, Indiana.
`
`2. Rothwell, Figg, Ernst & Manbeck P.C. retained KMT to conduct
`
`mechanical stiffness testing (also known as bend testing) on samples of endodontic
`
`files in accordance with ISO 3630-1.
`
`3.
`
`I oversaw that testing and prepared a report that summarizes the test
`
`materials, test methodology, testing equipment, and the test results. A copy of that
`
`report is attached to this declaration as Exhibit A.
`
`4. The testing described in Exhibit A was conducted in a laboratory at KMT
`
`at room temperature of approximately 21.5°C.
`
`5. The information contained in the report attached as Exhibit A is true and
`
`correct. The report attached as Exhibit A was prepared in the course of the
`
`regularly conducted business of KMT, at the time the testing was conducted, based
`
`on my personal knowledge.
`
`GOLD STANDARD EXHIBIT 2030
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`1
`
`
`
`I, Nolan Knight, affirm and declare as follows:
`
`1.
`
`I am the Engineering Manager at Knight Mechanical Testing, LLC
`
`("KMT"), an ISO/IEC 17025:2005 accredited independent mechanical testing
`
`laboratory located in Fort Wayne, Indiana.
`
`2. Rothwell, Figg, Ernst & Manbeck P.C. retained KMT to conduct
`
`mechanical stiffness testing (also known as bend testing) on samples of endodontic
`
`files in accordance with ISO 3630-1.
`
`3.
`
`I oversaw that testing and prepared a report that summarizes the test
`
`materials, test methodology, testing equipment, and the test results. A copy of that
`
`report is attached to this declaration as Exhibit A.
`
`4. The testing described in Exhibit A was conducted in a laboratory at KMT
`
`at room temperature of approximately 21.5°C.
`
`5. The information contained in the report attached as Exhibit A is true and
`
`correct. The report attached as Exhibit A was prepared in the course of the
`
`regularly conducted business of KMT, at the time the testing was conducted, based
`
`on my personal knowledge.
`
`GOLD STANDARD EXHIBIT 2030
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`1
`
`
`
`I declare under penalty of perjury that the following is true and correct.
`
`Executed on November 2-, 2015
`
`Nolan Knight
`
`2
`
`
`
`
`
`
`
`
`
`Exhibit A
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Title: 692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness
`Testing Final Report
`Final Report Date: 6/11/2014
`Revision Level: Initial
`Revision Date: 6/11/2014
`KMT Report Number: TR692-001
`Customer: Jason M. Nolan, Ph.D.
`Rothwell, Figg, Ernst & Manbeck
`607 14th Street, NW, Suite 800
`Washington, DC 20005
`KMT Project Number: 692RFE1666
`
`Subject
`EdgeEndo EdgeFile Endodontic Files:
`• X1-25.06 Heat Treated Fire Wire NiTi Reciprocating File, Reorder #: X1250625RF
`• X3-N2 Heat Treated Fire Wire NiTi Rotary File, Reorder #: X3170425RF
`• X5-40.04 Heat Treated Fire Wire NiTi Rotary File, Reorder #: X5400425RF
`• X7-35.06 Heat Treated Fire Wire NiTi Rotary File, Reorder #: X7350625RF
`• XR-R4 Rotary Retreatment File, Reorder #: XRR4250423
`
`Objective
`Perform ISO 3630-1 Section 7.5 Stiffness testing on the endodontic files.
`
`Background
`KMT Quotation Number: 000-1398
`Test Method/Protocol: ISO 3630-1:2008(E) Section 7.5 Stiffness
`Test Material Provided by: Rothwell, Figg, Ernst & Manbeck
`
`Test Method
`
`KMT Project
`Number
`
`KMT Load
`Frame (s)
`
`Test Start
`Date
`
`ISO 3630-1 Section 7.5
`Stiffness
`Table 1: Background summary table
`
`692RFE1666
`
`LF 16
`
`5/30/2014
`
`Test
`Completion
`Date
`6/2/2014
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`1/14
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`
`Test Material
`
`Test Material
`Description
`X1-25.06 Heat Treated Fire Wire
`NiTi Reciprocating File
`X3-N2 Heat Treated Fire Wire NiTi
`Rotary File
`X5-40.04 Heat Treated Fire Wire
`NiTi Rotary File
`X7-35.06 Heat Treated Fire Wire
`NiTi Rotary File
`XR-R4 Rotary Retreatment File
`
`Table 2: Test Material
`
`Test Equipment
`
`Test Equipment
`Description
`
`MTS Model 359.02 load
`frame
`Model TFF425 Reaction
`Torque Cell
`Trans-Tek Angular
`Displacement Transducer,
`Model 0605-0001
`MTS Model 493.10
`FlexTest GT Controller
`
`Omega CSC32
`Temperature Controller
`Omega Type K
`thermocouple probe TJ36-
`CASS-18U-6
`Mitutoyo Beveled
`Protractor
`
`KMT
`LF 16
`
`KMT
`CTL
`01
`KMT
`CNTR
`10
`KMT
`TP 10
`
`KMT
`MT 03
`
`Reorder #
`
`Lot
`
`Quantity
`
`X1250625RF
`
`022714014
`
`X3170425RF
`
`020614010
`
`X5400425RF
`
`060313013
`
`X7350625RF
`
`031014023
`
`XRR4250423
`
`022714092
`
`3
`
`3
`
`3
`
`3
`
`3
`
`Serial
`Number
`
`1027931
`
`Capacity
`
`Last
`Calibrated
`
`Next
`Calibration
`
`25 kN
`
`--
`
`--
`
`548288
`
`160 in-ozf
`
`5/16/2014
`
`5/31/2015
`
`K-11
`
`±140 deg
`
`1/24/2014
`
`1/31/2015
`
`02022807A
`
`558577020176
`
`--
`
`090051
`
`--
`
`--
`
`--
`
`--
`
`--
`
`--
`
`12/16/2013 12/31/2014
`
`2/28/2014
`
`2/28/2015
`
`12/16/2013 12/31/2014
`
`Table 3: Test Equipment
`
`2/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Fixturing
`KMT ISO 3630 Fixture, 0.65” Lever Arm
`
`Method
`
`ISO 3630-1 Section 7.5 Stiffness Test Setup
`Each endodontic file specimen was cut at the point at which the shank is attached to the shaft.
`The tip of endodontic file was clamped in the KMT ISO 3630 fixture perpendicular to the axis of
`the rotary actuator, to a depth of 3mm. The fixture was rigidly attached to the torque cell which
`was clamped to the load frame baseplate. A catch pin was mounted to the rotary actuator. The
`actuator was rotated until the catch pin was lightly touching the specimen and the angular
`displacement was set to zero. The actuator was then rotated until it reached an angular
`displacement of 45°. The applied torque was recorded for each file. See Figure 1 for a
`photograph of the test setup.
`
`Test Parameters
`
`Test Rate: 2 rpm
`Data Recording Rate: 128 Hz
`Table 4: Test Parameters
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`3/14
`
`
`
`
`
`
`
`
`Test Results
`
`ISO 3630-1 Section 7.5 Stiffness Test Results
`
`Description
`
`Reorder #
`
`Sample
`
`X1-25.06 Heat Treated Fire
`Wire NiTi Reciprocating File
`
`X1250625RF
`
`X3-N2 Heat Treated Fire
`Wire NiTi Rotary File
`
`X3170425RF
`
`X1_S1
`X1_S2
`X1_S3
`Avg.
`Std. Dev.
`X3_S1
`X3_S2
`X3_S3
`Avg.
`Std. Dev.
`X5_S1
`X5_S2
`X5_S3
`Avg.
`Std. Dev.
`X7_S1
`X7_S2
`X7_S3
`Avg.
`Std. Dev.
`XR_S1
`XR_S2
`XR_S3
`Avg.
`Std. Dev.
`Table 5: ISO 3630-1 Section 7.5 Stiffness Test Results
`
`X5-40.04 Heat Treated Fire
`Wire NiTi Rotary File
`
`X5400425RF
`
`X7-35.06 Heat Treated Fire
`Wire NiTi Rotary File
`
`X7350625RF
`
`XR-R4 Rotary Retreatment
`File
`
`XRR4250423
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Torque @ 45°
`Angular
`Displacement
`(mN-m)
`3.60
`3.53
`3.35
`3.49
`0.13
`0.93
`0.91
`1.35
`1.06
`0.25
`5.46
`4.85
`4.98
`5.09
`0.32
`6.49
`7.43
`7.44
`7.12
`0.55
`3.76
`3.43
`4.24
`3.81
`0.41
`
`Posttest
`Permanent
`Deformation
`Angle (deg)
`23.75
`27.00
`27.33
`26.03
`1.98
`1.83
`3.58
`2.17
`2.53
`0.93
`13.50
`11.75
`19.83
`15.03
`4.25
`29.00
`29.08
`26.67
`28.25
`1.37
`1.00
`0.25
`0.42
`0.56
`0.39
`
`See Appendix A for torque vs. angular displacement plots for the stiffness test. See Figures 2
`through 16 for posttest photographs of the test specimens.
`
`
`
`4/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Reported By:
`
`Nick Chadd - Test Engineer
`
`Date: 6/11/2014
`
`Reviewed By:
`Nolan Knight - Engineering Manager
`
`Date: 6/11/2014
`
`Revision
`Level
`-
`
`Revision /
`Review Date
`6/11/2014
`
`Initial release
`
`REVISION / REVIEW HISTORY
`
`Change
`
`Approved
`by
`NJK
`
`Date
`Approved
`6/11/2014
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`5/14
`
`
`
`IK~ I
`
`KNI GH T ME C HAI'\ICAL
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 1: ISO 3630-1 Section 7.5 Stiffness test setup
`6/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 2: Posttest sample X1_S1
`
`Figure 3: Posttest sample X1_S2
`
`7/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 4: Posttest sample X1_S3
`
`
`
`
`
`Figure 5: Posttest sample X3_S1
`
`8/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 6: Posttest sample X3_S2
`
`
`
`
`
`Figure 7: Posttest sample X3_S3
`
`9/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 8: Posttest sample X5_S1
`
`Figure 9: Posttest sample X5_S2
`
`10/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 10: Posttest sample X5_S3
`
`Figure 11: Posttest sample X7_S1
`
`11/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 12: Posttest sample X7_S2
`
`Figure 13: Posttest sample X7_S3
`
`12/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 14: Posttest sample XR_S1
`
`
`
`
`
`Figure 15: Posttest sample XR_S2
`
`13/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 16: Posttest sample XR_S3
`
`
`
`
`
`14/14
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`
`
`
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`TR692-001 692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final
`Report
`Appendix A: ISO 3630-1 Section 7.5 Stiffness Torque vs. Angular Displacement Plots
`
`A1/A4
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report– Appendix A
`
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`X1-25.06 Heat Treated Fire Wire NiTi Reciprocating File
`Reorder#: X1250625RF; Lot: 022714014
`KMT Project#: 692RFE1666
`
`10
`
`1S
`
`30
`2S
`20
`Angular Displacement (deg)
`
`3S
`
`40
`
`4S
`
`so
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`X3-N2 HeatTreated Fire Wire NiTi Rotary File
`Reorder#: X3170425RF; Lot: 020614010
`KMT Project#: 692RFE1666
`
`-
`
`-
`
`-
`
`X1 S1
`
`X1 S2
`
`X1 S3
`
`-
`
`-
`
`-
`
`X3S1
`
`X352
`
`X353
`
`10
`
`1S
`
`30
`2S
`20
`Angular Displacement (deg)
`
`3S
`
`40
`
`4S
`
`so
`
`A2/A4
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report– Appendix A
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`XS-40.04 Heat Treated Fire Wire NiTi Rotary File
`Reorder#: X5400425RF; Lot: 060313013
`KMT Project#: 692RFE1666
`
`10
`
`1S
`
`30
`2S
`20
`Angular Displacement (deg)
`
`3S
`
`40
`
`4S
`
`so
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`X7-35.06 Heat Treated Fire Wire NiTi Rotary File
`Reorder#: X7350625RF; Lot: 031014023
`KMT Project#: 692RFE1666
`
`-
`
`-
`
`-
`
`XSS1
`
`XSS2
`
`XSS3
`
`-
`
`-
`
`-
`
`X7S1
`
`X752
`
`X753
`
`"E s.o 1------------------~~----""----------
`z
`
`....
`
`.§_ . = ~ 40 l-----------c2tf.~"--------::.o.-=----------------
`"C . c.
`
`~ 3.0 1-- - - ----,,-:...-
`
`---:;;.-=- - - - - - - - - - - - - - - - - - - - - -
`
`10
`
`1S
`
`30
`2S
`20
`Angular Displacement (deg)
`
`3S
`
`40
`
`4S
`
`so
`
`A3/A4
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report– Appendix A
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`XR-R4 Rotary Retreatment File
`Reorder#: XRR4250423; Lot: 022714092
`KMT Project#: 692RFE1666
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`-
`
`-
`
`-
`
`XR51
`
`XR52
`
`XR53
`
`10
`
`15
`
`20
`30
`Angular Displacement (deg)
`
`25
`
`35
`
`40
`
`45
`
`so
`
`692RFE EdgeEndo EdgeFile ISO 3630-1 Section 7.5 Stiffness Testing Final Report– Appendix A
`Rev: Initial
`
`TR692-001
`6/11/2014
`
`A4/A4
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