FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780510437
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
017-23180
Catalog number
017-23180
Device description
Apex Locator, Mark VII™
Published
2018-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K032743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032743000APEX NRGMedicnrg , Ltd.2004-03-15LQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780510437PrimaryGS10
H834017231800SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178051043710381780510437

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

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