Alpen

Basic Information

• Brand Name: Alpen
• Primary DI: D661X863C0121
• Version / Model: X863C012
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-02-12
• Public Version: 2
• Public Version Date: 2020-03-23
• Public Version Status: Update
• Public Device Record Key: 63475a5a-2b8d-42bf-82ce-7e513738d3fb

Device Description

ALPEN X1 FLAME, COARSE

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Radiation Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJL	Bur, Dental	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16668	Carbide dental bur, reusable	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D661X863C0121	HIBCC
Unit of Use	D661X863C0120	HIBCC