SureSmile® ORX00006

GUDID D746ORX000060

SureSmile Dr Starter Kit, EU

DENTSPLY SIRONA ORTHODONTICS INC.

Dental abrasive strip, reusable
Primary Device IDD746ORX000060
NIH Device Record Key04c439e3-b78c-4731-92a4-6d479c72c089
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureSmile®
Version Model NumberORX00006
Catalog NumberORX00006
Company DUNS116903307
Company NameDENTSPLY SIRONA ORTHODONTICS INC.
Device Count2
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
EmailEssix.Sales@dentsplysirona.com
Phone+1(833)372-8255
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
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com
Phone+1(844)848-0137
Emailessix.sales@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746ORX000060 [Unit of Use]
HIBCCD746ORX000061 [Primary]

FDA Product Code

EHMSTRIP, POLISHING AGENT
EJBHANDLE, INSTRUMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-10
Device Publish Date2021-05-01

On-Brand Devices [SureSmile®]

D746ORX000060SureSmile Dr Starter Kit, EU
D746ORX000010SureSmile Dr Starter Kit
D746ORX000051SureSmile® Aligner Patient Kit (Global)

Trademark Results [SureSmile]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURESMILE
SURESMILE
97058764 not registered Live/Pending
Dentsply Sirona Orthodontics Inc.
2021-10-04
SURESMILE
SURESMILE
75818755 2724644 Live/Registered
ORAMETRIX, INC.
1999-10-08

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