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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535030822Brasseler USAPeter Brasseler Holdings, LLCNYC2026-07-13
05010058078147InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081406InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081666InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084582InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084599InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084605InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058178144InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181403InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181663InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184589InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184596InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184602InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081673InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
05010058181670InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
00850035489062Braces Treatment Starter KitzOrthonu LLCNYC2025-06-04
00850035489079Aligner Treatment Starter KitzOrthonu LLCNYC2025-06-04
05010058078123InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058178120InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058070158InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071230InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071414InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088788InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088849InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058170155InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171237InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171411InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188785InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188846InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
06970873260297Root Canal Instruments KitDENJOY DENTAL CO.,LTDNYC2022-02-19