FDA.reportPublic FDA data

Root Canal Instruments Kit

Primary DI
06970873260297
Brand
Root Canal Instruments Kit
Company
DENJOY DENTAL CO.,LTD
Model
DY21-1
Published
2022-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NYCDental Prophylaxis Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYCDental Prophylaxis KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970873260297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970873260297069708732602976970873260297

GMDN Terms#

Term, Definition table
TermDefinition
Dental examination kitA collection of various sterile dental instruments and the necessary materials (e.g., aspiration cannula, forceps, mirror, probe, spatula, excavator) intended to be used to perform a dental examination. It does not contain any pharmaceuticals and is not intended for surgical procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529329650
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06979865810014Gutta Percha CutterMeta Pack2026-03-31
06970873260389Integrated Endo System Meet Endo-II2025-02-28
06970873260013PULP TESTERDY3102022-02-19
06970873260051Endo Motor RCTI-DY(II)2022-02-19
06970873260068Endo Motor iMate-II2022-02-19
06970873260075Endo Motor iMate-II(IM2C)2022-02-19
06970873260082Cordless Gutta percha obturation system DY-GP2022-02-19
06970873260112Endo Rotary file K file, Machine super file, Machine H file, G file2022-02-19
06970873260143Gutta percha obturation system DY-GP Plus2022-02-19
06970873260167Medical MicroscopeiX62022-02-19
06970873260174Medical MicroscopeiX72022-02-19
06970873260181Medical MicroscopeiX82022-02-19
06970873260198Endo Motor Ai Mate-I2022-02-19
06970873260259Endo Motor Ai Mate-II2022-02-19
06970873260266Endo Motor iMate 32022-02-19
06970873260280Medical Face ShieldDF-202022-02-19
06970873260303 Dental Suction UnitDY-CX012022-02-19
06970873260310Intraoral CameraOrdinary model, standard model, luxury model2022-02-19
06970873260327Pulp Canal ReamerVertical pressure needle2022-02-19

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