FONA ELITE

GUDID D764B10730571

FONA ELITE STARTER KIT SIZE 2

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable
Primary Device IDD764B10730571
NIH Device Record Key02bf7ff3-4d19-4b6e-9d11-020c2f5fb123
Commercial Distribution StatusIn Commercial Distribution
Brand NameFONA ELITE
Version Model NumberB1073057
Company DUNS078613913
Company NameSIRONA DENTAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD764B10730571 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-10-21
Device Publish Date2016-09-09

On-Brand Devices [FONA ELITE]

D764B11110001FONA ELITE SENSOR SIZE 1 SHIP KIT
D764B10730591FONA ELITE STARTER KIT SIZE 0
D764B10730581FONA ELITE STARTER KIT SIZE 1
D764B10730571FONA ELITE STARTER KIT SIZE 2
D764B22721000FONA ELITE REMOTE ASSY
D764B22720001FONA ELITE REMOTE SHIP KIT
D764B13111000FONA ELITE SENSOR SIZE 0
D764B13110451FONA ELITE SENSOR SIZE 0 KIT
D764B13110001FONA ELITE SENSOR SIZE 0 SHIP KIT
D764B12111121FONA ELITE REPLACEABLE CABLE KIT 3 FT.
D764B12111111FONA ELITE REPLACEABLE CABLE KIT 9 FT.
D764B12111101FONA ELITE REPLACEABLE CABLE KIT 6 FT.
D764B12111000FONA ELITE SENSOR SIZE 2
D764B12110451FONA ELITE SENSOR SIZE 2 KIT
D764B12110001FONA ELITE SENSOR SIZE 2 SHIP KIT
D764B11111000FONA ELITE SENSOR SIZE 1
D764B11110451FONA ELITE SENSOR SIZE 1 KIT

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