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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

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