CDR

GUDID D764B24041001

CENTER AIMING RING*

SIRONA DENTAL, INC.

Dental x-ray film holder
Primary Device IDD764B24041001
NIH Device Record Key11819a86-16e1-468d-a175-3c2e8f6ed41c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDR
Version Model NumberB2404100
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 Numberfalse
Manufacturing Datefalse
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
Phone(877) 724-4254
Emailcustomerserviceny@sirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD764B24041001 [Primary]

FDA Product Code

EAPUnit, X-Ray, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


[D764B24041001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-03
Device Publish Date2016-09-09

On-Brand Devices [CDR]

D764B24041001CENTER AIMING RING*
D764B1104050R1CDR WIRED SIZE 1 REPLACEMENT
D764B10720061PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG)
D764B10720031PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG)
D764B10711021PHOENIX HOLDER SET SIZE 1
D764B24042001POSTERIOR AIMING RING*
D764B10730611UNIVERSAL STARTER KIT - SIZE 2
D764B10730601UNIVERSAL STARTER KIT - SIZE 1
D764B10720071PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG)
D764B10720051PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG)
D764B10720041PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG)
D764B10720021PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG)
D764B10720011PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG)
D764B10711031STANDARD HOLDER SET - SIZE 0
D764B10711001PHOENIX HOLDER SET SIZE 2 - SENSOR WITH SERIAL # ABOVE 604999
D764B10710601PHOENIX SNAP-A-RAY
D764B10710451PHOENIX VERTICAL BITE TAB SIZE 0 (25/PKG)
D764B10710421PHOENIX HORIZONTAL BITE TAB SIZE 0 (25/PKG)
D764B10710411PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 0 (25/PKG)
D764B10710271PHOENIX VERTICAL BITEWING HOLDER SIZE 1 (25/PKG)
D764B10710261PHOENIX ANTERIOR HOLDER SIZE 1 (25/PKG)
D764B10710251PHOENIX VERTICAL BITE TAB SIZE 1 (25/PKG)
D764B10710241PHOENIX PERIAPICAL HOLDER SIZE 1 (25/PKG)
D764B10710231PHOENIX HORIZONTAL BITEWING HOLDER SIZE 1 (25/PKG)
D764B10710221PHOENIX HORIZONTAL BITE TAB SIZE 1 (25/PKG)
D764B10710211PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 1 (25/PKG)
D764B10710071PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG)
D764B10710061PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG)
D764B10710051PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG)
D764B10710041PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG)
D764B10710031PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG)
D764B10710021PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG)
D764B10710011PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG)
D764B01220001POSTERIOR ARM*
D764B01210001BITEWING ARM*
D764B01200001ANTERIOR ARM*
D764B22501000CDR USB 2 INTERFACE ASSY
D764B2250000R1CDR REMOTE HS REPLACEMENT
D764B22500001USB REMOTE HS SHIP KIT
D764B13031000CDR SENSOR S0
D764B1303050R1CDR WIRED SIZE 0 REPLACEMENT
D764B13030501SENSOR SIZE 0
D764B12041000CDR SENSOR S2
D764B1204050R1CDR WIRED SIZE 2 REPLACEMENT
D764B12040501SENSOR SIZE 2
D764B11041000CDR SENSOR S1
D764B11040501SENSOR SIZE 1

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