SureSmile® Aligner ASSY-500016

GUDID 00856379007276

SureSmile Aligner (10 hours/day)

ORAMETRIX, INC.

Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner
Primary Device ID00856379007276
NIH Device Record Key2427c574-9a55-4140-9702-c557c69fa832
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureSmile® Aligner
Version Model Number1000
Catalog NumberASSY-500016
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856379007276 [Primary]

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 Date2022-05-09
Device Publish Date2022-04-29

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.