FDA.reportPublic FDA data

Apex File Grip (Set of 2)

Primary DI
D1001309252002
Brand
Apex File Grip (Set of 2)
Company
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Model
1
Catalog number
1309252002
Device description
The File-Grip (File-Clip) is an accessory used with the Apex Locator device. The File-Clip ensures a secure connection between the patient and the Apex Locator for accurate measurements.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQYLocator, Root ApexUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1001309252002PrimaryHIBCC0

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)1B00XSGOAC00062026-01-23
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
D1001309253002Apex Lip hook (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
04260482991227CanalPro Jeni SetSchlumbohm GmbH & Co. KGLQY2026-05-20
06941877829704EighteethChangzhou Sifary Medical Technology Co., Ltd.LQY2026-05-07
06942007309240ROGINShenzhen Rogin Medical Co., LtdLQY2026-04-14
06972214519064ROGINShenzhen Rogin Medical Co., LtdLQY2026-04-14
06972214519071ROGINShenzhen Rogin Medical Co., LtdLQY2026-04-14
04548213015641Root ZX miniJ.MORITA MFG.CORP.LQY2026-04-07
08033837938316CEFLACEFLA SOCIETA' COOPERATIVALQY2026-03-31
06979865810007Integrated Endo SystemDENJOY DENTAL CO.,LTDLQY2026-03-31
10194665008444A-decA-DEC, INC.LQY2026-02-19
10194665008475A-decA-DEC, INC.LQY2026-02-19
10194665008482A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.LQY2026-02-19
10194665008505A-decA-DEC, INC.LQY2026-02-19
10194665008512A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.LQY2026-02-19
10194665008550A-decA-DEC, INC.LQY2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHLQY2026-02-17
D100A102900000301PROPEX® Lip ClipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100A102900000401PROPEX® File ClipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100A103000000200Propex-Pixi Apex LocatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100A103100000301Propex Pixi® Apex Locator Long measurement cable with clipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSAL000000X-Smart Apex LocatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSALAC1000X-Smart® Apex Locator Measurement cableFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSALAC2000X-Smart® Apex Locator File clipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSALAC3000X-Smart® Apex Locator Lip clipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSALAC4000X-Smart® Apex Locator Touch probeFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSGOAC0001X-Smart® Go Measurement cableFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23
D100B00XSGOAC0002X-Smart® Go File clipFORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-01-23