`
`L
`
`Wayne, Indiana.
`
`LLC ("KMT"), an
`
`2. RothweH, Figg, Ernst Manbeck
`
`retained
`
`to conduct mechanical stiffness
`
`testing (also known as bend testing) on san1p1~~s of endodontic files
`
`accordance with ISO
`
`3.
`
`that sumn1arizes
`
`test materials, test
`
`methodology, testing equipment, and the test results. A copy
`
`report is attached to this
`
`declaration as Exhibit A.
`
`4.
`
`The test material identified in Exhibit A was received from
`
`Treating
`
`Company on January 14, 2015.
`
`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
`
`at the time the testing was conducted, based on my personal knowledge.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`Executed on January lfl, 2016
`
`Nolan Knight
`
`GOLD STANDARD EXHIBIT 2052
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`
`
`Exhibit A
`Exhibit A
`
`
`
`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:
`
`1118/2016
`
`Revision Level:
`
`Initial
`
`Revision Date:
`
`1/18/2016
`
`Customer:
`
`JasonM. Nolan, Ph.D.
`Rothwell, Figg, Ernst &
`Manbeck
`607 14th Street, NW, Suite 800
`Washington, DC 20005
`
`•
`Reported By:,...-~ ~--~ 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
`
`TRIII4-00I
`1/18/2016
`
`1112
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Revision
`Level
`Initial
`
`Revi~ion I
`Review Date
`1116/2016
`
`Initial release
`
`REVISION I REVIEW HISTORY
`
`C bange
`
`Approved
`by
`NK
`
`Date
`Approved
`1/18/2016
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TRIII4.QOI
`1/18/2016
`
`2/12
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Contents
`1 Subject ........................ ........ ........ .. .... ... .. ...... ..... .. .. .. .. .. .... .... .. ........ ... ... .. .. .......... ...... .. .. .. ... ... . 4
`2 Objective ............................................ ... .............. ...... ..... .... .... .. ... .. ....... .. ... .. .... .. .... .. ... .. ... ... . 4
`3 Background ........ ................. .. ......... ..... ........ ...... ............. .. ..... ..... ... .. ... .... .. ................ .... .. ... .... 4
`3.1
`Job Summary ................................................ ...... ............. ..... .. .... .................................. 4
`3.2 Testing Summary .......................................... .... .. ........ ............... ................................... 4
`4 Test Materia1. ..... ..... ...... ....... .... ... ........ ....... ............. .. ............................................................ 4
`ISO 3630-1 Section 7.5 Stiffness Test Materia1.. .......................................................... .4
`4.1
`5 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
`ISO 3630-1 Section 7.5 Stiffness Test Parameters ......................................................... 6
`6.2
`7 Test Results .... .. ... ..... ... ... .. ... ..... ... ...... .. ...... ....... .. ............ .. .. ............ ................. .................... 7
`7.1
`ISO 3630-1 Section 7.5 Stiffness Test Results ... ..... .... ........ ....... ... .. ............................... ?
`8 Photographs ... ...... ..... ..... ... .. .. ... .... .. ..... .... .. .. ......................................................... ............ ..... 8
`9 Appendix A: Test Plots ........................................................... .. ................ ..... .... .. ... ....... ... 12
`
`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 8
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`1 Subject
`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 Backgrou nd
`
`3 I
`
`Job Smnmarv
`KMT Job Number: 1114RFE
`Test Method/Protocol:
`ISO 3630-1:2008(E) Section 7.5 Stiffness
`Test Material Provided by: Kowalski Heat Treating Company
`
`Table 1: Job Summary
`
`3 2
`
`..
`Test.in!l Summarv
`'
`'
`
`Test Method
`
`KMT Project KMTLoad
`Frame (s)
`Number
`
`Test Start
`Date
`
`Test
`Completion
`Date
`
`ISO 3630-1 Section 7.5
`Stiffness
`
`Table 2: Testing Summary
`
`4 Test Material
`
`1114RFE2971
`
`LF16
`
`1115/2016
`
`1115/2016
`
`4 I
`
`Lot Number
`
`Quantity
`
`0000105683
`
`0000105683
`
`3
`
`3
`
`ISO 363 0-I Section 7 5 Stiffness T esr Maleri{l/
`Description
`Part Number
`PROFILE .04 Taper, Size 20, 25mm
`(Package A)
`PROFILE .04 Taper, Size 20, 25mm
`(Package B)
`
`PIT042025
`
`PIT042025
`
`Table 3: ISO 3630-1 Section 7.5 Stiffness Test Material
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-00I
`1/18/2016
`
`4/12
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`5 Equipment
`51 c l"b
`.
`IT E
`a 1 ratec e8l 1awvment
`Asset
`Tag
`
`Description
`
`KMT
`ADT
`06
`
`KMT
`CNTR
`09
`
`KMT
`LC 52
`
`KMT
`MT03
`
`KMT
`TP 7
`
`Trans-Tek Angular
`Displacement
`Transducer,Model 0605-
`0001
`
`OmegaCSC32
`Temperature Controller
`
`Futek Model MBA500 -
`axial/torque; 100 lb, 100
`inlb
`Mitutoyo Beveled
`Protractor
`Type K thermocouple
`probe TJ36-CASS-18U-6-
`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
`
`090051
`
`12/31/2015
`
`12/31/2016
`
`Omega
`Engineering,
`Inc.
`
`KMTTP7
`
`12/31/2015
`
`12/31/2016
`
`oa
`•rcunes an
`ll
`52 L d F:
`d C onlro ers
`Asset
`Description
`Tag
`KMT MTS Model359.02load frame, 25 kN capacity
`LF 16
`KMT
`CTL
`01
`
`MTS Model493.10 FlexTest GT Controller
`
`Table 5: Load Frames and Controllers
`
`5. 3 Fix turing
`I KMT ISO 3630 FixtuJ·e, 0.65" Lever Arm
`
`Table 6: Fixturing
`
`Manufacturer
`
`Serial#
`
`MTS
`
`MTS
`
`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 Parameten
`Test Rate: 2rpm
`Data Recording Rate: 128Hz
`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
`
`TR\114-001
`1/18/2016
`
`6/12
`
`
`
`7 Test Results
`
`7.1
`
`ISO 3630-1 Section 7.5 Stiffiutss 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
`
`
`
`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-l Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TRIII4-00 l
`111 8120 16
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`Figure 2: Posttest Package A Sample Sl
`
`Figure 3: Posttest Package A Sample S2
`
`9/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TRII14-00I
`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 Sl
`
`10112
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TRlll4-001
`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
`
`
`
`3205 Clairmont Ct. Suite B
`Fort Wayne, IN 46808
`Phone: (260) 489-1444
`Fax: (260) 818-2036
`
`9 A eudix 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 If: 1114RFE2971
`
`3.0
`
`2.0 I
`Ju
`I 1.11
`
`~
`
`2.0
`
`iu
`
`f I
`
`~ ~o
`
`ISO 3630·1:2008 Section 7.5 Stiffness
`PROFILE .04 Taper, Size 20, 25mm (Package B)
`Part#: PIT042025; Lot If: 0000105683
`KMT Project If: 1114RFE2971
`
`-
`Sl
`-
`52
`---u
`
`-
`-
`
`st
`52
`
`-S3
`
`0~
`
`Ahlol.ol Dhpl.._ • ._ (d I
`
`12/12
`
`ProFile Rotary File ISO 3630-1 Section 7.5 Stiffness Testing Final Report
`Rev: Initial
`
`TR1114-001
`1/18/2016