FDA.reportPublic FDA data

Aria® Expressions®

Primary DI
00190707193119
Brand
Aria® Expressions®
Company
Ortho Organizers, Inc.
Model
716-394CH-HK-10
Device description
Aria® Expressions® .022 Roth LL5 HK -22T 0A 4DO (10)
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707193119PrimaryGS10
10190707193116Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707193119001907071931191907071931190190707193119
1019070719311610190707193116

Regulatory Flags#

DUNS number
062165188
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
D829B770000000M0051Metal Triple Edge ButtonEC Certification Service GmbHEJF2026-11-05
D829B770000000M0101Metal Triple Edge ButtonEC Certification Service GmbHEJF2026-11-05
D829B770000000M0501Metal Triple Edge ButtonEC Certification Service GmbHEJF2026-11-05
00197998062162SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062179SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062414SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062421SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062438SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062445SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062452SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062469SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062742SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062759SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062858SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062889SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062902SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063145SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063442SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063459SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063466SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063473SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063589SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063596SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063602SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063619SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063626SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063633SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063640SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063657SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063664SolventumSolventum Orthodontics CorporationEJF2026-11-04