FDA.reportPublic FDA data

Aligner Hole Punch Plier

Primary DI
G443CSC303AT0
Brand
Aligner Hole Punch Plier
Company
CHURAHI SURGICAL CO.
Model
CSC303AT
Catalog number
CSC303AT
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G443CSC303AT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645513524
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G443CSC2011Ligature director and tuckerCSC-201CSC-2012023-08-08
G443CSC2031Double-Ended Distal End BenderCSC-203CSC-2032023-08-08
G443CSC2121Mathieu Needle HolderCSC-212CSC-2122023-08-08
G443CSC2201MBT Bracket Height GaugeCSC-220CSC-2202023-08-08
G443CSC2311Bracket Tweezer with SlotCSC-231CSC-2312023-08-08
G443CSC2321Bracket Tweezer Tube HoldingCSC-232CSC-2322023-08-08
G443CSC2331Bracket Tweezer small PointCSC-233CSC-2332023-08-08
G443CSC1021Weingart Universal PlierCSC-102CSC-1022023-08-07
G443CSC1031Lingual Weingart PlierCSC-103CSC-1032023-08-07
G443CSC1121Distal end CutterCSC-112CSC-1122023-08-07
G443CSC1131Distal end Flush CutterCSC-113CSC-1132023-08-07
G443CSC1211Pin & Ligature CutterCSC-121CSC-1212023-08-07
G443CSC1311Bracket Remover Straight PlierCSC-131CSC-1312023-08-07
G443CSC1601Hammer Head PlierCSC-160CSC-1602023-08-07
G443CSC184000Tischler Biopsy ForcepCSC18400CSC184002023-06-06
G443CSC184010Baby Tischler ForcepCSC18401CSC184012023-06-06
G443CSC301AT0Aligner Horizontal PlierCSC301ATCSC301AT2023-06-05
G443CSC302AT0Aligner Vertical PlierCSC302ATCSC302AT2023-06-05
G443CSC304AT0Aligner Retention PlierCSC304ATCSC304AT2023-06-05
G443CSC300AT0Aligner Tear Drop PlierCSC300ATCSC300AT2023-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840539702450ExperienceGc Orthodontics America Inc.JEX2026-05-28
07898488905107WEINGART PLIER W/OUT WIDIAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488907217TUBE CONVERSION PLIER – 4003ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705803TORQUE PLIER SHORT (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611200129PLIER FOR LONG TORQUE (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611210074"PROMO KIT ICERAM-P MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2024-04-16
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07895742204273MorelliDental Morelli LtdaJEX2021-04-30
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