NIC or SUPERLINE

FDA UDI

Class U (US FDA UDI)

by Shenzhen Superline Technology Co., Ltd.

Identity

Trade Name: NIC or SUPERLINE FDA UDI
Generic Name: Endodontic apex locator FDA UDI
Device Name: Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment. FDA UDI
Model / Reference: Alpha Apex I FDA UDI
Description: Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment. FDA UDI

Identifiers

Primary DI / UDI-DI: 06944835199918 FDA UDI
510(k) Number: K242765 FDA UDI
FDA Product Code: LQY FDA UDI
GMDN Term: Endodontic apex locator FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endodontic apex locator

NIC or SUPERLINE by Shenzhen Superline Technology Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PATTERSON — PATTERSON DENTAL SUPPLY, INC. · U
DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · U
EndoPilot Komet — Schlumbohm GmbH & Co. KG · U
Henry Schein — HENRY SCHEIN, INC. · U
EndoPilot Cap for lip-contact — Schlumbohm GmbH & Co. KG · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Shenzhen Superline Technology Co., Ltd.

Sources (1)

FDA UDI 926fbac9-d2d2-4094-887b-4d1515103322 36 fields · synced May 30, 2026