FDA.reportPublic FDA data

Twin Force® Locking Tool

Primary DI
00190707059262
Brand
Twin Force® Locking Tool
Company
Ortho Organizers, Inc.
Model
424-213TI
Device description
Twin Force® Double Ended Locking Tool
Published
2019-05-08
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
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707059262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707059262001907070592621907070592620190707059262

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210074"PROMO KIT ICERAM-P MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2024-04-16
07898506853069QuinelatoSchobell Industrial LtdaJEX2023-01-10
07898506814039QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506814244QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506841318QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506848669QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506850228QuinelatoSchobell Industrial LtdaJEX2022-12-16
07895742204273MorelliDental Morelli LtdaJEX2021-04-30
ESAM6005001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6011001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6015001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6026001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6028001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6030001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6034001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6045001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6047001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6071001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6073131STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6075001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6078001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6080001STOMA®Storz am Mark GmbHJEX2020-08-27
08033707076841LEONE SPALEONE SPAJEX2020-05-11
08033707096108LEONE SPALEONE SPAJEX2020-05-11
08033707082378LEONE SPALEONE SPAJEX2020-05-09
08033707082408LEONE SPALEONE SPAJEX2020-05-09
08033707082415LEONE SPALEONE SPAJEX2020-05-09
08033707084624LEONE SPALEONE SPAJEX2020-05-09
08033707084631LEONE SPALEONE SPAJEX2020-05-09
08033707084648LEONE SPALEONE SPAJEX2020-05-09