AccessGUDID - DEVICE: NIC or SUPERLINE (06944835199918)

GUDID

Device Identifier (DI) Information

Brand Name: NIC or SUPERLINE
Version or Model: Alpha Apex I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Superline Technology Co., Ltd.

Primary DI Number: 06944835199918
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2030
Device Count: 50
Labeler D-U-N-S® Number*: 527943851 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQY	Locator, Root Apex

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242765	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 926fbac9-d2d2-4094-887b-4d1515103322
Public Version Date: May 06, 2025
Public Version Number: 1
DI Record Publish Date: April 28, 2025