AccessGUDID - DEVICE: Endo@pex (08800017900001)

GUDID

Device Identifier (DI) Information

Brand Name: Endo@pex
Version or Model: Endo@pex
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DXM CO., LTD

Primary DI Number: 08800017900001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688797315 *Terms of Use

Device Description: The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully delivers predictable results in vertical condensation and 3 dimensional thermo-plasticized obturation. The 2 most effective individual obturation device (Friendo, Gutta Easy) are beautifully combined as one convenient package for maximum efficiency

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
45227	Root canal obturation kit	A collection of sterile dental devices, synthetic materials, and solutions designed to permanently prime, seal, and fill a tooth undergoing a root canal procedure. This device typically includes materials such as a primer (for bonding to the walls of the canal), a sealer (for bonding to the primer), and endodontic points and pellets (for the filling). This bonding process creates a monoblock filling resulting in increased resistance to bacteria penetration and fracture for root canal-treated teeth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKR	Plugger, Root Canal, Endodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 60 and 106 KiloPascal
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89b3c388-0ccd-442c-95c5-12b99ca44c55
Public Version Date: June 27, 2023
Public Version Number: 1
DI Record Publish Date: June 19, 2023