FDA.reportPublic FDA data

OrthoFlow®

Primary DI
00817645020009
Brand
OrthoFlow®
Company
Six Month Smiles
Model
904R
Catalog number
904R
Device description
OrthoFlow® - Indirect Bond 1.5g (Indirect Bonding)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817645020009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817645020009008176450200098176450200090817645020009

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118919669
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817645020191Porcelain Conditioner901R2021-02-08
00817645020184Assure Plus908R2021-02-05
008176450201776MS Aligners800-ALN2019-07-17
00817645020207Indirect Bonding Tray700D2023-03-16
00817645020016OrthoMax®905R905R2016-09-24
00817645020023Lucid-Lok™20320-120320-12016-09-24
00817645020030Lucid-Lok™20301203012016-09-24
00817645020047Lucid-Lok™20302203022016-09-24
00817645020054Lucid-Lok™20303203032016-09-24
00817645020061Lucid-Lok™20304203042016-09-24
00817645020078Lucid-Lok™20305203052016-09-24
00817645020085Lucid-Lok™20306203062016-09-24
00817645020092Lucid-Lok™20307203072016-09-24
00817645020108Lucid-Lok™20308203082016-09-24
00817645020115Lucid-Lok™20311203112016-09-24
00817645020122Lucid-Lok™20312203122016-09-24
00817645020139Lucid-Lok™20313203132016-09-24
00817645020146Lucid-Lok™20321203212016-09-24
00817645020160OrthoMax®906R06R2018-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262957068OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
08809262957075OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
08809262957082OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073571SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062988SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062995SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063008SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063015SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063176SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063190SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063206SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063244SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063251SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063268SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063275SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063299SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063305SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063312SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24