SureSmile Aligner Software

GUDID 00856379007085

ORAMETRIX, INC.

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software
Primary Device ID00856379007085
NIH Device Record Keyae04ed76-7080-45c8-9d38-2fb4e1e8d767
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureSmile Aligner Software
Version Model Number7.6
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
GS100856379007085 [Primary]

FDA Product Code

EIAUnit, operative dental
NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-15
Device Publish Date2020-07-07

Devices Manufactured by ORAMETRIX, INC.

00856379007283 - Motto2023-03-16 Motto Aligner
00856379007290 - Motto2023-03-16 Motto Attachment Template
00856379007306 - Motto2023-03-16 Motto Retainer
00856379007122 - SureSmile®2022-05-17 Arch wire 16round CUNITI-NITI
00856379007139 - SureSmile®2022-05-17 Arch wire 16x22 CUNITI-NITI
00856379007146 - SureSmile®2022-05-17 Arch wire 17x25 CUNITI-NITI
00856379007153 - SureSmile®2022-05-17 Arch wire 19x25 CUNITI-NITI
00856379007160 - SureSmile®2022-05-17 Arch wire 17x25 ELGILOY

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