FRC Postec Plus Reamer

Basic Information

• Brand Name: FRC Postec Plus Reamer
• Primary DI: DIVO572801AN1
• Version / Model: 572801AN
• Catalog Number: 572801AN
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Labeler DUNS: 448015938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 1
• Public Version Date: 2020-09-03
• Public Version Status: New
• Public Device Record Key: 74fa2bf9-7f56-4396-9676-e6d473c30b05

Device Description

FRC Postec Plus Reamer Refill Size 1

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKP	REAMER, PULP CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64833	Endodontic instrument-holding insert, reusable	A device intended to be fitted into a container designed to store endodontic instruments (e.g., files/rasps), typically chairside prior to a clinical procedure or during a sterilization procedure. It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	DIVO572801AN0	HIBCC
Primary	DIVO572801AN1	HIBCC