3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final
`Report
`
`KMT Report Number:
`
`TR1114-001
`
`Final Report Date:
`
`1/18/2016
`
`Revision Level:
`
`Initial
`
`Revision Date:
`
`1/18/2016
`
`Customer:
`
`Jason M. Nolan, Ph.D.
`Rothwell, Figg, Ernst &
`Manbeck
`607 14th Street, NW, Suite 800
`Washington, DC 20005
`
`ReportedBy:,~ ~
`Date: 1/18/2016
`Nick Chadd- Test Engineer
`
`Date: 1/18/2016
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`1112
`
`TR1114-001
`1118/2016
`GOLD STANDARD EXHIBIT 2036
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Revision
`Level
`Initial
`
`Revision /
`Review Date
`1/16/2016
`
`Initial release
`
`REVISION / REVIEW HISTORY
`
`Change
`
`Approved
`by
`NK
`
`Date
`Approved
`1/18/2016
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`2/12
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`4
`
`5
`
`Contents
`1
`Subject.................................................................................................................................4
`2 Objective .............................................................................................................................4
`3
`Background..........................................................................................................................4
`3.1
`Job Summary ................................................................................................................4
`3.2
`Testing Summary..........................................................................................................4
`Test Material........................................................................................................................4
`4.1
`ISO 3630-1 Section 7.5 Stiffness Test Material .............................................................4
`Equipment............................................................................................................................5
`5.1
`Calibrated Test Equipment............................................................................................5
`5.2
`Load Frames and Controllers ........................................................................................5
`5.3
`Fixturing .......................................................................................................................5
`6 Method ................................................................................................................................6
`6.1
`ISO 3630-1 Section 7.5 Stiffness Test Setup .................................................................6
`6.2
`ISO 3630-1 Section 7.5 Stiffness Test Parameters.........................................................6
`Test Results .........................................................................................................................7
`7.1
`ISO 3630-1 Section 7.5 Stiffness Test Results...............................................................7
`Photographs .........................................................................................................................8
`8
`9 Appendix A: Test Plots .....................................................................................................12
`
`7
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`3/12
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Subject
`1
`ProFile .04 Taper Rotary File, Size 20, 25mm, Part #: PIT042025
`
`2 Objective
`Perform ISO 3630-1 Section 7.5 Stiffness testing on the endodontic files.
`
`3 Background
`
`3.1
`
`Job Summary
`KMT Job Number: 1114RFE
`ISO 3630-1:2008(E) Section 7.5 Stiffness
`Test Method/Protocol:
`Test Material Provided by: Kowalski Heat Treating Company
`Table 1: Job Summary
`
`3.2
`
`Testing Summary
`
`Test Method
`
`ISO 3630-1 Section 7.5
`Stiffness
`Table 2: Testing Summary
`
`4 Test Material
`
`KMT Project
`Number
`
`KMT Load
`Frame (s)
`
`1114RFE2971
`
`LF16
`
`Test Start
`Date
`
`1/15/2016
`
`Test
`Completion
`Date
`1/15/2016
`
`4.1
`
`ISO 3630-1 Section 7.5 Stiffness Test Material
`Description
`Part Number
`PROFILE .04 Taper, Size 20, 25mm
`PIT042025
`(Package A)
`PROFILE .04 Taper, Size 20, 25mm
`(Package B)
`Table 3: ISO 3630-1 Section 7.5 Stiffness Test Material
`
`PIT042025
`
`Lot Number
`0000105683
`
`0000105683
`
`Quantity
`3
`
`3
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`4/12
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`5 Equipment
`
`5.1 Calibrated Test Equipment
`Asset
`Description
`Tag
`Trans-Tek Angular
`KMT
`Displacement
`ADT
`Transducer,Model 0605-
`06
`0001
`KMT
`Omega CSC32
`CNTR
`Temperature Controller
`09
`Futek Model MBA500 -
`KMT
`axial/torque; 100 lb, 100
`LC 52
`inlb
`KMT
`Mitutoyo Beveled
`MT 03
`Protractor
`Type K thermocouple
`KMT
`probe TJ36-CASS-18U-6-
`TP 7
`OSTW-M
`Table 4: Calibrated Test Equipment
`
`Manufacturer
`
`Serial #
`
`Calibrated Calibration
`Due
`
`Trans-Tek
`
`E0018
`
`4/6/2015
`
`4/30/2016
`
`Omega
`Engineering,
`Inc.
`
`558577020
`195
`
`12/31/2015
`
`12/31/2016
`
`Futek
`
`561224
`
`11/13/2015
`
`11/30/2016
`
`Mitutoyo
`Omega
`Engineering,
`Inc.
`
`090051
`
`12/31/2015
`
`12/31/2016
`
`KMTTP7
`
`12/31/2015
`
`12/31/2016
`
`Load Frames and Controllers
`5.2
`Asset
`Description
`Tag
`KMT
`LF 16 MTS Model 359.02 load frame, 25 kN capacity
`KMT
`CTL
`01
`Table 5: Load Frames and Controllers
`
`MTS Model 493.10 FlexTest GT Controller
`
`Fixturing
`5.3
`KMT ISO 3630 Fixture, 0.65” Lever Arm
`Table 6: Fixturing
`
`Manufacturer
`
`MTS
`
`MTS
`
`Serial #
`
`1027931
`
`02022807A
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`5/12
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`6 Method
`
`ISO 3630-1 Section 7.5 Stiffness Test Setup
`6.1
`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.
`
`6.2
`
`ISO 3630-1 Section 7.5 Stiffness Test Parameters
`Test Rate: 2 rpm
`Data Recording Rate: 128 Hz
`Test Environment: Ambient air 23°C ±2°C
`Table 7: ISO 3630-1 Section 7.5 Stiffness Test Parameters
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`6/12
`
`

`
`7 Test Results
`
`7.1
`
`ISO 3630-1 Section 7.5 Stiffness Test Results
`
`Description
`
`Part #
`
`Lot #
`
`Sample
`
`PROFILE .04 Taper,
`Size 20, 25mm
`(Package A)
`
`PIT042025
`
`0000105683
`
`PROFILE .04 Taper,
`Size 20, 25mm
`(Package B)
`
`PIT042025
`
`0000105683
`
`Table 8: ISO 3630-1 Section 7.5 Stiffness Test Results
`
`S1
`S2
`S3
`Avg.
`Std. Dev.
`S1
`S2
`S3
`Avg.
`Std. Dev.
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Torque @ 45°
`Angular
`Displacement
`(mN-m)
`2.59
`2.08
`2.01
`2.23
`0.31
`2.30
`1.41
`2.04
`1.92
`0.46
`
`Posttest
`Permanent
`Deformation
`Angle (deg)
`0.00
`0.33
`0.67
`0.33
`0.33
`0.42
`0.92
`0.00
`0.44
`0.46
`
`See Appendix A for torque vs. angular displacement plots for the stiffness test. See Figures 2
`through 7 for post-test photographs of the test specimens.
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`7/12
`
`

`
`8
`
`Photographs
`
`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
`8/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 2: Posttest Package A Sample S1
`
`Figure 3: Posttest Package A Sample S2
`
`9/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 4: Posttest Package A Sample S3
`
`Figure 5: Posttest Package B Sample S1
`
`10/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`

`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 6: Posttest Package B Sample S2
`
`Figure 7: Posttest Package B Sample S3
`
`11/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016
`
`

`
`9 Appendix A: Test Plots
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`PROFILE .04 Taper, Size 20, 2Smm (Package A)
`Part#: PIT042025; Lot#: 0000105683
`KMT Project#: 1114RFE2971
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`-
`
`51
`
`- ~
`
`-
`
`53
`
`An1ular Di$pl;~cement [des)
`
`ISO 3630-1:2008 Section 7.5 Stiffness
`PROFILE .04 Taper, Size 20, 2Smm (Package B)
`Part#: PIT042025; Lot#: 0000105683
`KMT Project#: 1114RFE2971
`
`10
`
`II
`
`lO
`JO
`25
`An1ular Oispl;~cement (des)
`
`35
`
`40
`
`45
`
`12/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016