CDR

GUDID D764B22500001

USB REMOTE HS SHIP KIT

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D764B22500001
• NIH Device Record Key: 10fc3e70-f8b1-4cc8-9065-91dcb83c09d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDR
• Version Model Number: B2250000
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B22500001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933455

FDA Product Code

• EAP: Unit, X-Ray, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-09
• Device Publish Date: 2016-09-09

On-Brand Devices [CDR]

• D764B24041001: CENTER AIMING RING*
• D764B1104050R1: CDR WIRED SIZE 1 REPLACEMENT
• D764B10720061: PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG)
• D764B10720031: PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG)
• D764B10711021: PHOENIX HOLDER SET SIZE 1
• D764B24042001: POSTERIOR AIMING RING*
• D764B10730611: UNIVERSAL STARTER KIT - SIZE 2
• D764B10730601: UNIVERSAL STARTER KIT - SIZE 1
• D764B10720071: PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG)
• D764B10720051: PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG)
• D764B10720041: PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG)
• D764B10720021: PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG)
• D764B10720011: PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG)
• D764B10711031: STANDARD HOLDER SET - SIZE 0
• D764B10711001: PHOENIX HOLDER SET SIZE 2 - SENSOR WITH SERIAL # ABOVE 604999
• D764B10710601: PHOENIX SNAP-A-RAY
• D764B10710451: PHOENIX VERTICAL BITE TAB SIZE 0 (25/PKG)
• D764B10710421: PHOENIX HORIZONTAL BITE TAB SIZE 0 (25/PKG)
• D764B10710411: PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 0 (25/PKG)
• D764B10710271: PHOENIX VERTICAL BITEWING HOLDER SIZE 1 (25/PKG)
• D764B10710261: PHOENIX ANTERIOR HOLDER SIZE 1 (25/PKG)
• D764B10710251: PHOENIX VERTICAL BITE TAB SIZE 1 (25/PKG)
• D764B10710241: PHOENIX PERIAPICAL HOLDER SIZE 1 (25/PKG)
• D764B10710231: PHOENIX HORIZONTAL BITEWING HOLDER SIZE 1 (25/PKG)
• D764B10710221: PHOENIX HORIZONTAL BITE TAB SIZE 1 (25/PKG)
• D764B10710211: PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 1 (25/PKG)
• D764B10710071: PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG)
• D764B10710061: PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG)
• D764B10710051: PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG)
• D764B10710041: PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG)
• D764B10710031: PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG)
• D764B10710021: PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG)
• D764B10710011: PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG)
• D764B01220001: POSTERIOR ARM*
• D764B01210001: BITEWING ARM*
• D764B01200001: ANTERIOR ARM*
• D764B22501000: CDR USB 2 INTERFACE ASSY
• D764B2250000R1: CDR REMOTE HS REPLACEMENT
• D764B22500001: USB REMOTE HS SHIP KIT
• D764B13031000: CDR SENSOR S0
• D764B1303050R1: CDR WIRED SIZE 0 REPLACEMENT
• D764B13030501: SENSOR SIZE 0
• D764B12041000: CDR SENSOR S2
• D764B1204050R1: CDR WIRED SIZE 2 REPLACEMENT
• D764B12040501: SENSOR SIZE 2
• D764B11041000: CDR SENSOR S1
• D764B11040501: SENSOR SIZE 1