Advanced Endodontic System

Basic Information

• Brand Name: Advanced Endodontic System
• Primary DI: 00850309007329
• Version / Model: 90-2250E
• Catalog Number: 90-2250E
• Company Name: ASI MEDICAL, INC.
• Labeler DUNS: 808695159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6c43d2b9-ab66-4c95-93a1-30b55992dfce

Device Description

Advanced Endodontic System

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LQY	Locator, Root Apex	Unknown		U
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1
EKR	Plugger, Root Canal, Endodontic	Dental	872.4565	1
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	872.4200	1
EBZ	Activator, Ultraviolet, For Polymerization	Dental	872.6070	2
DZI	Drill, Bone, Powered	Dental	872.4120	2
EIA	Unit, Operative Dental	Dental	872.6640	1
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60930	Dental delivery system instrument unit, electric	A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850309007329	GS1

Premarket Submissions

Submission Number	Supplement Number
K123139	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity