CDR ELITE

GUDID D764B11070011

CDR ELITE SENSOR SHIP KIT S1, 9FT

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D764B11070011
• NIH Device Record Key: f9dd55ca-18eb-4d05-b0dd-257cc3a573d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDR ELITE
• Version Model Number: B1107001
• 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	D764B11070011 [Primary]

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-12-09
• Device Publish Date: 2016-09-09

On-Brand Devices [CDR ELITE]

• D764B12070021: CDR ELITE SENSOR SHIP KIT S2, 3FT
• D764B13170531: SCHICK ELITE SIZE 0 - 3' REPLACEMENT
• D764B13170521: SCHICK ELITE SIZE 0 - 9' REPLACEMENT
• D764B13170511: SCHICK ELITE SIZE 0 - 6' REPLACEMENT
• D764B13072000: CDR ELITE SENSOR S0
• D764B13070021: CDR ELITE SENSOR SHIP KIT S0, 3FT
• D764B13070011: CDR ELITE SENSOR SHIP KIT S0, 9FT
• D764B13070001: CDR ELITE SENSOR SHIP KIT S0, 6FT
• D764B12170531: SCHICK ELITE SIZE 2 - 3' REPLACEMENT
• D764B12170521: SCHICK ELITE SIZE 2 - 9' REPLACEMENT
• D764B12170511: SCHICK ELITE SIZE 2 - 6' REPLACEMENT
• D764B12072000: CDR ELITE SENSOR S2
• D764B12070011: CDR ELITE SENSOR SHIP KIT S2, 9FT
• D764B12070001: CDR ELITE SENSOR SHIP KIT S2, 6FT
• D764B11170531: SCHICK ELITE SIZE 1 - 3' REPLACEMENT
• D764B11170521: SCHICK ELITE SIZE 1 - 9' REPLACEMENT
• D764B11170511: SCHICK ELITE SIZE 1 - 6' REPLACEMENT
• D764B11072000: CDR ELITE SENSOR S1
• D764B11070021: CDR ELITE SENSOR SHIP KIT S1, 3FT
• D764B11070011: CDR ELITE SENSOR SHIP KIT S1, 9FT
• D764B11070001: CDR ELITE SENSOR SHIP KIT S1, 6FT