Endo-Express

Basic Information

• Brand Name: Endo-Express
• Primary DI: 00766054001201
• Version / Model: 5510-00
• Catalog Number: 5510-00
• 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: 2020-07-10
• Public Version: 2
• Public Version Date: 2023-11-23
• Public Version Status: Update
• Public Device Record Key: afaafb14-7a7c-4330-bc0e-cf6e6fd88837
• Distribution End Date: 2022-01-01

Device Description

Endo-Express E Type 4-Hole Air Motor

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGS	Handpiece, contra- and right-angle attachment, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054001201	GS1

Customer Contacts

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