Universal Holders

GUDID D764B10731071

Universal Bitewing Holder - Red

SIRONA DENTAL, INC.

Dental x-ray film holder, single-use

• Primary Device ID: D764B10731071
• NIH Device Record Key: 59dd3d2d-70f7-4e58-b8dd-861ac071df8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Holders
• Version Model Number: B1073107
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	D764B10731071 [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 [Universal Holders]

• D764B10731081: Universal Anterior Holder - Blue
• D764B10731071: Universal Bitewing Holder - Red
• D764B10731061: Universal Endodontic Holder
• D764B10731041: Universal Anterior Holder
• D764B10731031: Universal Endodontic Tab Holder
• D764B10731021: Universal Bitewing Holder
• D764B10731011: Universal Bite Tab Holder
• D764B10730621: UNIVERSAL HOLDERS STARTER KIT