FDA.reportPublic FDA data

TruFit™

Primary DI
10190707156500
Brand
TruFit™
Company
Ortho Organizers, Inc.
Model
491-91-4610-340-3
Device description
TruFit™ 2.0 ASM .018 ROTH LL6 CONV SBT -25T 4DOff 34.0 (3PK)
Published
2025-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707156503PrimaryGS10
10190707156500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707156503001907071565031907071565030190707156503
1019070715650010190707156500

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
3
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
10190707068148VARIABLE FORCE 3™ THERMAL NITANIUM® ARCHWIRE104-9672026-01-07
10190707086494Triumph®205-0112026-01-07
00190707086503Triumph®205-206B2026-01-07
10190707086517Triumph®205-206T2026-01-07
10190707086524Triumph®205-207T2026-01-07
10190707086531Triumph®205-207TT2026-01-07
00190707102975Carriere® Motion Pro™425-818C2024-01-16
00190707103002Carriere® Motion Pro™425-820C2024-01-16
00190707103033Carriere® Motion Pro™425-823C2024-01-16
00190707103064Carriere® Motion Pro™425-825C2024-01-16
00190707103095Carriere® Motion Pro™425-827C2024-01-16
00190707075972Maestro® Band Assemblies902-351061E2020-07-14
00190707096755Reveal® Aligners139-61042022-01-06
00190707096762Reveal® Aligners139-61052022-01-06
00190707096779Reveal® Aligners139-61062022-01-06
00190707096786Reveal® Aligners139-61072022-01-06
00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018667815Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECM2025-11-06
10190707120051TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120068TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120075TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120082TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120099TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120105TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120112TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120129TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120136TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120143TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120150TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120167TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120174TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120181TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120198TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120204TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120211TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120228TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120235TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120242TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120259TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120266TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120273TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120280TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120297TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120303TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120310TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120327TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120334TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17