Endo-Eze AET Contra Angle

Basic Information

• Brand Name: Endo-Eze AET Contra Angle
• Primary DI: 00883205021076
• Version / Model: 3219-
• Catalog Number: 3219-
• Company Name: ULTRADENT PRODUCTS, INC.
• Labeler DUNS: 013369913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-04
• Public Version: 1
• Public Version Date: 2018-10-05
• Public Version Status: New
• Public Device Record Key: f26abc78-d737-4747-805e-0c128675cd42

Device Description

ENDO CONTRA ANGLE LOANER

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: No
• PM Exempt: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFB	Handpiece, air-powered, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34699	Dental laboratory drilling system motor	A mains electricity (AC-powered) engine (motor) used in a dental laboratory in conjunction with a flexible drive system (e.g., a Bowden cable) to provide the rotational power for a dental laboratory handpiece. It is typically combined with different speed controllers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883205021076	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992380	000