FDA.reportPublic FDA data

X-Smart® Go Contra-angle (6:1)

Primary DI
D100B00XSGOAC0006
Brand
X-Smart® Go Contra-angle (6:1)
Company
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Model
1
Catalog number
B00XSGOAC0006
Device description
A dental contra angle is a handpiece for endodontic rotary files, which is used in dentistry to reach the mouth's most difficult-to-reach locations. The contra angle rotates 360° so that the display can always be viewed easily
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
LQYLocator, Root ApexUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D100B00XSGOAC0006PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic apex locatorA dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532219235
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D1001309252002Apex File Grip (Set of 2)113092520022026-05-27
D1001309253002Apex Lip hook (Set of 2)12026-05-27
D100A102900000301PROPEX® Lip Clip1A1029000003012026-01-23
D100A102900000401PROPEX® File Clip1A1029000004012026-01-23
D100A103000000200Propex-Pixi Apex Locator1A1030000002002026-01-23
D100A103100000301Propex Pixi® Apex Locator Long measurement cable with clip1A1031000003012026-01-23
D100B00XSAL000000X-Smart Apex LocatorX-Smart ALB00XSAL0000002026-01-23
D100B00XSALAC1000X-Smart® Apex Locator Measurement cable1B00XSALAC10002026-01-23
D100B00XSALAC2000X-Smart® Apex Locator File clip1B00XSALAC20002026-01-23
D100B00XSALAC3000X-Smart® Apex Locator Lip clip1B00XSALAC30002026-01-23
D100B00XSALAC4000X-Smart® Apex Locator Touch probe1B00XSALAC40002026-01-23
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorX-Smart GoB00XSGO0000002026-01-23
D100B00XSGOAC0001X-Smart® Go Measurement cable1B00XSGOAC00012026-01-23
D100B00XSGOAC0002X-Smart® Go File clip1B00XSGOAC00022026-01-23
D100B00XSGOAC0003X-Smart® Go Lip clip1B00XSGOAC00032026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeve1B00XSGOAC00072026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bank1BSPXSGOAC00052026-01-23
07290114352000Spotter Device (without accessories)SPR5-SPR-0002024-09-18
17290114352007Spotter Device SetSPR2024-09-18
17290114352106Spotter Demo setDemo2024-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKX2026-09-24
06944843624365Ultrapro TX CordlessULTRADENT PRODUCTS, INC.EKX2026-09-19
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
D1001309252002Apex File Grip (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
D1001309253002Apex Lip hook (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08