Dentsply Sirona SureSmile VPro Manual De Instrucciones

LABELING CHANGE REQUEST FORM
CONSUMABLE GROUP QUALITY SYSTEM – SINGLE-USE FORM
RECORD NUMBER
Labelling Action Types
Product Name
Product SKU #
Labelling (artwork)
reference
Actual labelling/artwork
Revision
Smartsolve revision n° of
the record.
Labelling Title
Change Initiator / Date
Description of Change
(What is changing?)
Reason / Justification for
Change (Why?)
Labelling Type
Required translations:
Download center:
☐Website update needed? (IFU, Marketing material, Symbol glossary)
Inventory disposition:
☐Use inventories as is (mixing allowed)
☐Refer to change plan for inventory disposition
☒Other, describe: Deplete Rev 15, rolling transition to Rev. 16. Changes captured in eIFU acceptable during
inventory transition
☐ N/A, justify:
(no need to fill below
☐N/A:
- Specified in ERP System
- Specified in Controlled Document (e.g.: artwork): site specific specification #
- N/A (Artwork not intended for printing)
Trim Size:
Varnish
Specialty
Ink/Colors
# of Folds
Stock
Other
IFU Finished Size (Folded)
FORM NO
0060-MKTG-PRT-10238
Change request Details
☒Change with change plan:
CHANGE-PLN-2023-526
SureSmile VPro Vibration Device, SureSmile VPro Mouthpiece
V18100, V18102
PRT-10238
16
16
SureSmile VPro and Mouthpiece Instructions for Use
Margaret Jacob
☐ New item If not, please describe:
ICES-Gen General Copmpliance for Interference-Causing Equipment (ICES-Gen Issue 2
February 23, 2024)
☐Packaging
☐Labels
List of languages to be displayed here (8000-FM-007-05 and/or list of intended markets
defined during the NPD and/or change control process)
EN, DA, DE, ES, FI, FR, IS, IT, MY, NL, NO, PL, PT, RO, SV, TH, TR, VI
Implementation Checklist
Material & Printing Specifications (optional)
section):
8" x 5"
TT Polyester Laminate
☐Yes
☐Spot
Black
☐ N/A
40# White Text
84 pages
4" x 5"
8000-FM-007-01
☐ Change Without change
plan
Add FCC IC Canadian warnings to EN and FR
☒IFUs-Manuals
☐Symbol glossary
Finished Size (Label, Packaging, IFU
folded):
Binding
☒No
☐Corner Stapled
☒Booklet (Saddle Stitched)
☐Flood
Bleeds
Single or Double Sided
REVISION LEVEL
PAGE NO Page 1 of 1
☐ New (initial release)
☐Marketing Communications
/Advertising
☐Tip cards- Technical Guide-
Getting Started Guide
4" x 5"
☒N/A
☐Other
☐Yes ☒No
☐Single Sided
☒Double Sided
3