Intraoral Sensor Holder

GUDID D764B10731561

Sirona Endo Holder Assy Kit

SIRONA DENTAL, INC.

Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use

• Primary Device ID: D764B10731561
• NIH Device Record Key: cc225e36-3b79-417e-b7a1-39adbc86eec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraoral Sensor Holder
• Version Model Number: B1073156
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B10731561 [Primary]

FDA Product Code

• EGZ: Holder, Film, X-Ray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Intraoral Sensor Holder]

• D764B10731581: Sirona Anterior Holder Assembly Kit - Blue
• D764B10731571: Sirona Bitewing Holder Assembly Kit - Red
• D764B10731561: Sirona Endo Holder Assy Kit
• D764B10731551: Sirona Periapical Holder Assy Kit Yellow
• D764B10731531: Sirona Endodontic Tab Assy Kit Green