DOCUMENT TITLE Calamus Flow Obturation Delivery Device...Size:7” Length X 8.5” Height ±...
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DOCUMENT TITLE Calamus Flow Obturation Delivery Device DOCUMENT NUMBER SP-FOEMC01801 REVISION 12 For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval PAGE 1 of 9 TP-0035 Rev. 02 (3/12) Directions for Use Size:7” Length X 8.5” Height ± 0.062” Color: Black Ink
Transcript of DOCUMENT TITLE Calamus Flow Obturation Delivery Device...Size:7” Length X 8.5” Height ±...
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 1 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use
Size:7” Length X 8.5” Height ± 0.062”
Color: Black Ink
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 2 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 3 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 4 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 5 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 6 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 7 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 8 of 9
TP-0035 Rev. 02 (3/12)
Directions for Use (continued)
DOCUMENT TITLE
Calamus Flow Obturation Delivery Device DOCUMENT NUMBER
SP-FOEMC01801 REVISION
12
For Use By Affiliates of DENTSPLY Tulsa Dental Specialties This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
PAGE 9 of 9
TP-0035 Rev. 02 (3/12)
REVISION HISTORY Revision/date Description of change
00 – 3/13/06 New specification. Replaces Old SP-05874-Dist
01 – 4/27/07 Removed DFU. This has been combined into the Directions for use. Changed Instruction Manual to Directions for use. Update to new artwork Revised to change name to Tulsa Dental Specialties for DFU, DVD Label, System Label and Tip Card. Revision 00 of this specification is approved for use until 12/31/07
02 – 7/30/07 Update to new artwork for all items (except MSDS) Revision 01 of this specification is approved for use until stock is exhausted
03 – 9/6/07 Added Overlay artwork. Add Alternate label for loaners
04 - 12/19/07 Corrected overlay label
05 – 1/20/10 Added serial number label to box label
06 – 4/23/10 Added label for RFBCAL (Refurbished units). Reference PCO 616
07 – 8/1/2011 Added Reference Card
08 – 10/13/11 Added Outer Box GP Expiration Date Label. Revised Reference Card to remove patents and update regulatory information. Removed Tip Card because Reference card has duplicate information. Disposition: Current product inventory. Allow a 3 month phase in (Dentsply Tulsa Specialties is distributor) from the issue date of revision 08. Reference PCO 786
9 – 1/29/2013 Revised tip card…removed “implants” from logo; revised SKU & revision level; updated product trademark from ™ to ®. Pack: updated “consult instructions for use” symbol. Discard remaining stock after new cards are received.
10 – 1/7/2015 Revise DFU correcting grammatical errors, changed CE mark from 0459 to 0086. Reference PCO 1086. Revised chassis adding do not throw away symbol, changed CE mark number, removed patents, added Calamus and Dentsply logo’s, and updated contact information for both Tulsa and Aseptico. Removed MSDS’s.
11 Added AEU-35T Accessory Box Label. It was originally added to SP-FOEMC01809 in error.
12 Removed label information. Spec moved to the 1000 repository under 1000-TF_2_Kitlabel_000008. No CC needed.
