FDA.reportPublic FDA data

Motto

Primary DI
00856379007306
Brand
Motto
Company
ORAMETRIX, INC.
Model
ASSY-500019
Catalog number
ASSY-500019
Device description
Motto Retainer
Published
2023-03-08
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
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856379007306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856379007306008563790073068563790073060856379007306

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856379007313SureSmile®2000ASSY5000202026-05-20
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
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
08054154160044EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154160068EQULIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154160082EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154160242EQUILIBRATORE C4PEPTAMED SRLKMY2026-08-27
08054154161041EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161058EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161065EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161072EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161096EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161102EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161218EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161225EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161232EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161249EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161256EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161263EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161270EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161294EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161300EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161317EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161324EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161331EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161348EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161355EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161362EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161379EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161386EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161591EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161607EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161614EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27