FDA.reportPublic FDA data

NIC or SUPERLINE

Primary DI
06944835199918
Brand
NIC or SUPERLINE
Company
Shenzhen Superline Technology Co., Ltd.
Model
Alpha Apex I
Device description
Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment.
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K242765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242765000Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.2025-01-17LQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944835199918PrimaryGS10
01069448351999Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944835199918069448351999186944835199918
01069448351999010694483519991069448351999

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
527943851
Device count
50
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944835130195NIC/SUPERLINEAlpha Endo2025-12-22
06944835190366NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190410NIC or SUPERLINE Barrel 2025-09-18
06944835190496NIC or SUPERLINEDonut2025-09-18
06944835190571NIC or SUPERLINECylinder Flat End2025-09-18
06944835190816NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190281NIC or SUPERLINEInverted Cone 2025-09-18
06944835190373NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190427NIC or SUPERLINE Barrel 2025-09-18
06944835190502NIC or SUPERLINEDonut2025-09-18
06944835190588NIC or SUPERLINECylinder Flat End2025-09-18
06944835190823NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190007NIC or SUPERLINERound2025-09-17
06944835190014NIC or SUPERLINERound2025-09-17
01069448351999NIC or SUPERLINEAlpha Apex I2025-04-28

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