Intraoral Sensor Holders Arms and Rings

Basic Information

• Brand Name: Intraoral Sensor Holders Arms and Rings
• Primary DI: D764B02100001
• Version / Model: B0210000
• Company Name: SIRONA DENTAL, INC.
• Labeler DUNS: 078613913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: e8b68d2a-996d-42d0-bfaa-77075b8e1f9c

Device Description

Anterior Arm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHA	Aligner, Beam, X-Ray	Dental	872.1820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D764B02100001	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]