FDA.reportPublic FDA data

SureSmile Ortho Software

Primary DI
00856379007092
Brand
SureSmile Ortho Software
Company
ORAMETRIX, INC.
Model
7.6
Catalog number
DIGI-500153
Device description
SureSmile Ortho Software
Published
2020-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856379007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856379007092008563790070928563790070920856379007092

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856379007313SureSmile®2000ASSY5000202026-05-20
90856379007118SureSmile® DIGI-500128DIGI-5001282021-05-28
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
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08
10817417021538AsepticoASEPTICO, INC.EIA2022-12-08
10817417021545AsepticoASEPTICO, INC.EIA2022-12-08
10817417021552AsepticoASEPTICO, INC.EIA2022-12-08
10817417021569AsepticoASEPTICO, INC.EIA2022-12-08
10817417021576AsepticoASEPTICO, INC.EIA2022-12-08
10817417021583AsepticoASEPTICO, INC.EIA2022-12-08
10817417021590AsepticoASEPTICO, INC.EIA2022-12-08
10817417021606AsepticoASEPTICO, INC.EIA2022-12-08
10817417021613AsepticoASEPTICO, INC.EIA2022-12-08
10817417021835AsepticoASEPTICO, INC.EIA2022-12-08
10817417021842AsepticoASEPTICO, INC.EIA2022-12-08