FDA.reportPublic FDA data

Orthodontic Instruments

Primary DI
00190707069766
Brand
Orthodontic Instruments
Company
ORTHO ORGANIZERS, INC.
Model
200-127
Device description
Twirl-On Ligature Placer
Published
2020-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707069766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707069766001907070697661907070697660190707069766

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic ligature directorA hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
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
B382SD91427410030Surgical DirectSurgical Direct, Inc.JEX2026-02-09
B382SD9142761200Surgical DirectSurgical Direct, Inc.JEX2026-02-09
00190746065477Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746065507Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067426Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067440Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
10190707086494Triumph®Ortho Organizers, Inc.JEX2026-01-07
00190707086503Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086517Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086524Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086531Triumph®Ortho Organizers, Inc.JEX2026-01-07
D9098000041SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800022S1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063C1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063L1ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980007214ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980008417SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980008518SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980023515RAZOROrtho Arch Company IncJEX2025-09-15
D90980023919RAZOROrtho Arch Company IncJEX2025-09-15
D909800239T1RAZOROrtho Arch Company IncJEX2025-09-15
D90980024011RAZOROrtho Arch Company IncJEX2025-09-15
D90980024112RAZOROrtho Arch Company IncJEX2025-09-15
D90980024213RAZOROrtho Arch Company IncJEX2025-09-15
D9098002761ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002771ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002781ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002791ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980013817ORTHO ARCHOrtho Arch Company IncJEX2025-08-27
04963931274291NAYDM CORPORATIONJEX2025-07-11