FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040110598
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701441
Catalog number
5701441
Device description
Maxima Apex Locator Lip Hooks
Published
2019-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LQYLocator, root apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQYLocator, Root ApexUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181087000Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd.2018-12-18LQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040110598PrimaryGS10
00304040110591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404011059810304040110598
00304040110591003040401105913040401105910304040110591

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

Regulatory Flags#

DUNS number
012430880
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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