NIC or SUPERLINE

Basic Information

• Brand Name: NIC or SUPERLINE
• Primary DI: 06944835199918
• Version / Model: Alpha Apex I
• Company Name: Shenzhen Superline Technology Co., Ltd.
• Labeler DUNS: 527943851
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2025-04-28
• Public Version: 1
• Public Version Date: 2025-05-06
• Public Version Status: New
• Public Device Record Key: 926fbac9-d2d2-4094-887b-4d1515103322
• Distribution End Date: 2030-03-25

Device Description

Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LQY	Locator, Root Apex	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	01069448351999	GS1
Primary	06944835199918	GS1

Premarket Submissions

Submission Number	Supplement Number
K242765	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius