EDENTA

Basic Information

• Brand Name: EDENTA
• Primary DI: E312PIN020010001
• Version / Model: PIN0200-1000
• Company Name: EDENTA ETABLISSEMENT
• Labeler DUNS: 448002915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• 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: 95d39dc5-5516-4a64-bec0-f6d2bffa1ace

Device Description

Dowel Pin No.2 medium

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: No

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
35868	Dental restoration retention pin	A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E312PIN02001000101	HIBCC
Primary	E312PIN020010001	HIBCC