SureSmile attachment template

GUDID 00856379007047

ORAMETRIX, INC.

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Primary Device ID00856379007047
NIH Device Record Keye2d137b2-c349-4140-bc90-612d03e38063
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureSmile attachment template
Version Model Number3000
Company DUNS053101262
Company NameORAMETRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com
Phone+1(844)848-0137
EmailSureSmile-Customer-Care@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856379007047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-02
Device Publish Date2019-07-25

On-Brand Devices [SureSmile attachment template]

008563790070302000
008563790070473000

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