N/A ART01-R

GUDID D746ART01R1

Appliance Remover Tool - Retail

DENTSPLY SIRONA ORTHODONTICS INC.

Orthodontic appliance remover
Primary Device IDD746ART01R1
NIH Device Record Key9998a10a-da3f-48ae-9219-f8769e0cac5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberART01-R
Catalog NumberART01-R
Company DUNS116903307
Company NameDENTSPLY SIRONA ORTHODONTICS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746ART01R1 [Primary]

FDA Product Code

EIYInstrument, Filling, Plastic, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-24
Device Publish Date2021-12-16

On-Brand Devices [N/A]

D807K190055001MTM® NO TRACE (TM) 018 UL/4-4
D807K189551921In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK
D807K100551921In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK
D80738331071TEW T 018/U&L3 WD 7T STD
D80738322141TEW T 022/U2 MED 14T STD
D80738321141TEW T 018/U2 MED 14T STD
D80738311221TEW T 018/U1 WD 22T
D80738282251TEW 022/L6 WD -25T STD
D80738282101TEW 022/L6 WD -10T STD
D80738221141TEW 018/U2 MED 14T STD
D80738211471TEW 018/U1 XWD 22T
D80738211221TEW 018/U1 WD 22T STD
D80738211151TEW 018/U1 WD 15T STD
D80737691121LWS T 018/L1-2 NAR
D80737442221TEW D 022/U&L4-5 MED
D80737392221TEW T 022/L1-2 MED
D80737391221TEW T 018/L1-2 MED
D80737391121TEW T 018/L1-2 NAR
D80737382421TEW T 022/U&L6 XWD
D80737382321TEW T 022/U&L6 WD
D80737381321TEW T 018/U&L6 WD
D80737362101TEW T 022/L1-2 NAR LP TAP
D80737361201TEW T 018/L1-2 MED LP TAP
D80737361101TEW T 018/L1-2 NAR LP TAP
D80737352211TEW T 022/U4-5 MED OW TAP
D80737352201TEW T 022/L4-5 MED LP TAP
D80737351211TEW T 018/U4-5 MED OW TAP
D80737342321TEW T 022/U&L4-5 WD
D80737342221TEW T 022/U&L4-5 MED
D80737341221TEW T 018/U&L4-5 MED
D80737337321TEW T 022/UL3 WD PST
D80737336321TEW T 022/UR3 WD PST
D80737332321TEW T 022/U&L3 WD
D80737332221TEW T 022/U&L3 MED
D80737332201TEW T 022/L3 MED LP
D80737331321TEW T 018/U&L3 WD
D80737331221TEW T 018/U&L3 MED
D80737322221TEW T 022/U2 MED
D80737321221TEW T 018/U2 MED
D80737312421TEW T 022/U1 XWD
D80737312321TEW T 022/U1 WD
D80737311421TEW T 018/U1 XWD
D80737311321TEW T 018/U1 WD
D80737292221TEW 022/L1-2 MED
D80737292121TEW 022/L1-2 NAR
D80737291221TEW 018/L1-2 MED
D80737291121TEW 018/L1-2 NAR
D80737282421TEW 022/U&L6 XWD
D80737282321TEW 022/U&L6 WD
D80737281421TEW 018/U&L6 XWD
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