FONA ELITE

Basic Information

• Brand Name: FONA ELITE
• Primary DI: D764B10730571
• Version / Model: B1073057
• Company Name: SIRONA DENTAL, INC.
• Labeler DUNS: 078613913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 6
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: 02bf7ff3-4d19-4b6e-9d11-020c2f5fb123

Device Description

FONA ELITE STARTER KIT SIZE 2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2
EHD	Unit, X-Ray, Extraoral With Timer	Dental	872.1800	2
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D764B10730571	HIBCC

Customer Contacts

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