FDA.reportPublic FDA data

SureSmile®

Primary DI
00856379007313
Brand
SureSmile®
Company
ORAMETRIX, INC.
Model
2000
Catalog number
ASSY500020
Device description
SureSmile Aligner
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXCAligner, sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856379007313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856379007313008563790073138563790073130856379007313

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)848-0137SureSmile-Customer-Care@dentsplysirona.com

Regulatory Flags#

DUNS number
053101262
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90856379007118SureSmile® DIGI-500128DIGI-5001282021-05-28
00856379007092SureSmile Ortho Software 7.6DIGI-5001532020-07-07
00856379007108SureSmile Advanced Software7.6DIGI-5001592020-07-07
00856379007047SureSmile attachment template3000ASSY-5000102019-07-25
00856379007023SureSmile®1000ASSY-5000112018-09-10
00856379007085SureSmile Aligner Software 7.62020-07-07
00856379007283MottoASSY-500118ASSY-5000182023-03-08
00856379007290MottoASSY-500017ASSY-5000172023-03-08
00856379007306MottoASSY-500019ASSY-5000192023-03-08
00856379007122SureSmile®ASSY-000108ASSY-0001082021-05-28
00856379007139SureSmile®ASSY-000109ASSY-0001092021-05-28
00856379007146SureSmile®ASSY-000110ASSY-0001102021-05-28
00856379007153SureSmile®ASSY-000112ASSY-0001122021-05-28
00856379007160SureSmile®ASSY-000115ASSY-0001152021-05-28
00856379007177SureSmile®ASSY-000116ASSY-0001162021-05-28
00856379007184SureSmile®ASSY-000117ASSY-0001172021-05-28
00856379007191SureSmile®ASSY-000149ASSY-0001492021-05-28
00856379007207SureSmile®ASSY-000469ASSY-0004692021-05-28
00856379007214SureSmile®ASSY-000470ASSY-0004702021-05-28
00856379007221SureSmile®ASSY-000471ASSY-0004712021-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850004223307CandidProCANDID CARE CO.NXC2026-09-04
00850004223413CandidProCANDID CARE CO.NXC2026-09-04
08800142100963TERA HARZ CLEARGraphy Inc.NXC2026-08-21
08800142100987TERA HARZ CLEARGraphy Inc.NXC2026-08-21
08800142100994TERA HARZ CLEARGraphy Inc.NXC2026-08-21
00850004223253CandidProCANDID CARE CO.NXC2026-07-27
00850004223260CandidProCANDID CARE CO.NXC2026-07-27
00850004223314ProMonitoringCANDID CARE CO.NXC2026-07-27
00850004223352ProMonitoringCANDID CARE CO.NXC2026-07-27
00850004223383OlivCANDID CARE CO.NXC2026-07-27
00850004223390OlivCANDID CARE CO.NXC2026-07-27
00850004223550CandidProCANDID CARE CO.NXC2026-07-27
06956748704394LUMOSCOWuxi EA Medical Instruments Technologies Limited.NXC2026-05-12
D77595102Smart Moves Complete Phase 1 TraysGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AASS0Super Spring AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ABLR0Bloore Removable AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AII0Invisible Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIA0Lower Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIAW0Lower Inman Aligner 'Wireless' Great Lakes Dental Technologies, Ltd.NXC2026-05-07
06956748700198Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-05-06
00197998216398Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216428Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216435Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216480Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216527Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216534Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216572Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216596Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216657Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216664Clarity™Solventum Orthodontics CorporationNXC2026-04-25