FDA.reportPublic FDA data

SureSmile®

Primary DI
D746ORX000051
Brand
SureSmile®
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
ORX00005
Device description
SureSmile® Aligner Patient Kit (Global)
Published
2021-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYCDental Prophylaxis Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYCDental Prophylaxis KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D746ORX000051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic positioner support kitA collection of devices intended to be used to facilitate use of an orthodontic teeth positioner, including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic positioner seater, and an orthodontic appliance cleanser. The aligner, appliance or positioner is not included. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)848-0137essix.sales@dentsplysirona.com

Regulatory Flags#

DUNS number
116903307
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D746EPOO4W1PonticEPOO4-WEPOO4-W2016-09-24
D746EPOO4Y1PonticEPOO4-YEPOO4-Y2016-09-24
D746RBTPC1RETAINER BRITE®RB-TP-CRB-TP-C2021-05-01
D746ELA6G1Lower Anterior PonticELA6-GELA6-G2016-09-24
D746ELA6W1Lower Anterior PonticELA6-WELA6-W2016-09-24
D746ELA6Y1Lower Anterior PonticELA6-YELA6-Y2016-09-24
D746EUT6W1Essix®EUT6-WEUT6-W2016-09-24
D746EUT6Y1Essix®EUT6-YEUT6-Y2016-09-24
D746PLMOG1Posterior Lower PonticPLMO-GPLMO-G2016-09-24
D746PLMOW1Posterior Lower PonticPLMO-WPLMO-W2016-09-24
D746PLMOY1Posterior Lower PonticPLMO-YPLMO-Y2016-09-24
D746PUMOG1Posterior Lower PonticPUMO-GPUMO-G2016-09-24
D746PUMOW1Posterior Lower PonticPUMO-WPUMO-W2016-09-24
D746PUMOY1Posterior Lower PonticPUMO-YPUMO-Y2016-09-24
D746SUA6W1Square Upper PonticSUA6-WSUA6-W2016-09-24
D746SUA6Y1Square Upper PonticSUA6-YSUA6-Y2016-09-24
D746TUA6G1EssixTUA6-GTUA6-G2016-09-24
D746TUA6W1EssixTUA6-WTUA6-W2016-09-24
D746TUA6Y1EssixTUA6-YTUA6-Y2016-09-24
D74640035BL1SpaceFile®40035-BL40035-BL2021-12-16

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Primary DI, Brand, Company table
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