SafeSiders

Basic Information

• Brand Name: SafeSiders
• Primary DI: 00766054001225
• Version / Model: 5000-06
• Catalog Number: 5000-06
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Labeler DUNS: 101147171
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 2
• Public Version Date: 2022-10-19
• Public Version Status: Update
• Public Device Record Key: 044d2285-032b-4838-b5f3-935ba6d711ef
• Distribution End Date: 2022-10-01

Device Description

SafeSiders Endo Stops

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45123	Endodontic stopper	A device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end of the instrument (e.g., an endodontic file) allowing the operator to gauge the maximum depth of penetration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054001225	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]