EDENTA

Basic Information

• Brand Name: EDENTA
• Primary DI: E3122038101
• Version / Model: 2038-10
• Company Name: EDENTA ETABLISSEMENT
• Labeler DUNS: 448002915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-02-03
• Public Version: 1
• Public Version Date: 2022-02-11
• Public Version Status: New
• Public Device Record Key: 400c0576-0990-469a-a137-6cbf11c4dcfb

Device Description

Mandrel 4 mm Extension for

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16701	Dental restoration retention pin kit	A collection of various dental instruments, devices and materials intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations such as fillings and crowns. It is typically presented as a kit and contains, e.g., retention pins of incrementing sizes, a selection of dental drills, and the necessary instruments to facilitate the procedure. This is a reusable device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E312203810101	HIBCC
Primary	E3122038101	HIBCC