ABSORBENT PAPER POINTS

Basic Information

• Brand Name: ABSORBENT PAPER POINTS
• Primary DI: 08806383517652
• Version / Model: SPILL PROOF ENDO ORGANIZER EPP1 15/40
• Catalog Number: 301-201
• Company Name: DiaDent Group International
• Labeler DUNS: 687789453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-14
• Public Version: 1
• Public Version Date: 2020-05-22
• Public Version Status: New
• Public Device Record Key: 0ca076c6-4651-4132-b770-3a6f0916a75a

Device Description

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKN	Point, Paper, Endodontic	Dental	872.3830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38777	Endodontic paper point	A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806383517652	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and away from Sunlight