FDA.reportPublic FDA data

Aligner Tear Drop Plier

Primary DI
G443CSC300AT0
Brand
Aligner Tear Drop Plier
Company
CHURAHI SURGICAL CO.
Model
CSC300AT
Catalog number
CSC300AT
Device description
Orthodontic Pliers are positive locking plier intended for holding, placing, and tying ligatures and elastics. They also can be used for grasping and guiding a needle when suturing.
Published
2023-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
G443CSC300AT0PrimaryHIBCC0

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
G443CSC303AT0Aligner Hole Punch PlierCSC303ATCSC303AT2023-06-05
G443CSC304AT0Aligner Retention PlierCSC304ATCSC304AT2023-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G8791050120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
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G8791050770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
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G8791051390DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
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G8791051530DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
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G8791053020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
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