FDA.reportPublic FDA data

Votion™

Primary DI
00190707109844
Brand
Votion™
Company
Ortho Organizers, Inc.
Model
351-21-3620
Device description
Votion™ .018 LR6 NC SBT -20T 0A 0DDO DB (10PK)
Published
2025-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707109844PrimaryGS10
10190707109841Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707109844001907071098441907071098440190707109844
1019070710984110190707109841

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
062165188
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707195014Retainer Wire682932026-10-20
00190707133207Band Assemblies900-123061E-0202025-07-07
00190707134341Band Assemblies900-124061E-0202025-07-07
00190707140021Band Assemblies900-103061E-032025-07-07
00190707140366Band Assemblies900-104061E-032025-07-07
00190707141387Band Assemblies900-123061E-032025-07-07
00190707141516Band Assemblies900-124061E-032025-07-07
00190707192976Aria® Expressions®716-303CH-102026-08-27
00190707192983Aria® Expressions®716-304CH-102026-08-27
00190707192990Aria® Expressions®716-321CH-102026-08-27
00190707193003Aria® Expressions®716-322CH-102026-08-27
00190707193010Aria® Expressions®716-333CH-102026-08-27
00190707193027Aria® Expressions®716-351CH-HK-102026-08-27
00190707193034Aria® Expressions®716-352CH-HK-102026-08-27
00190707193041Aria® Expressions®716-359CH-HK-102026-08-27
00190707193058Aria® Expressions®716-360CH-HK-102026-08-27
00190707193065Aria® Expressions®716-369CH-HK-102026-08-27
00190707193072Aria® Expressions®716-370CH-HK-102026-08-27
00190707193089Aria® Expressions®716-389CH-HK-102026-08-27
00190707193096Aria® Expressions®716-390CH-HK-102026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998070198SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070204SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070211SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075063SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075674SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101670SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101694SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107887SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107900SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253386SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253393SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253409SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253416SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253423SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253430SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253447SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253454SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253461SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253478SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253485SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253492SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253508SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253515SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253522SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253539SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253546SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253553SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253560SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253577SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253584SolventumSolventum Orthodontics CorporationDZD2026-10-24