FDA.reportPublic FDA data

Ortho Technology®

Primary DI
00190707192969
Brand
Ortho Technology®
Company
Ortho Organizers, Inc.
Model
98165D
Device description
Comfort Cover-No outside Label 5 sets per pack
Published
2025-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBand, elastic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707192969PrimaryGS10
10190707192966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707192969001907071929691907071929690190707192969
1019070719296610190707192966

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

Regulatory Flags#

DUNS number
062165188
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00190707193102Aria® Expressions®716-393CH-HK-102026-08-27
00190707193119Aria® Expressions®716-394CH-HK-102026-08-27
00190707193126Aria® Expressions®716-399CHQ2026-08-27
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22