CDR ELITE

GUDID D764B11072000

CDR ELITE SENSOR S1

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: D764B11072000
• NIH Device Record Key: 10dc75c4-f2a5-4d3c-8e07-e60c20ea06ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDR ELITE
• Version Model Number: B1107200
• 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: false
• 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	D764B11072000 [Primary]

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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