Advanced Endodontic System

Basic Information

• Brand Name: Advanced Endodontic System
• Primary DI: 00850309007183
• Version / Model: 90-2125E
• Catalog Number: 90-2125E
• 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: c082e56e-9373-4eb9-8c69-c386c6162884

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
60390	Laparoscopic wound closure thread	A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850309007183	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