Round duraforce

Basic Information

• Brand Name: Round duraforce
• Primary DI: D746DFS030X100R1
• Version / Model: DFS030X100R
• Catalog Number: DFS030X100R
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2024-01-26
• Public Version Status: Update
• Public Device Record Key: 08dadf0a-3680-46d4-9a62-ea8033a82578
• Distribution End Date: 2021-02-18

Device Description

Round duraforce sheets .030" x.125mm.100-pack

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, prescription	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47974	Dental implant x-ray template	A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D746DFS030X100R1	HIBCC
Unit of Use	D746DFS030X100R0	HIBCC

Customer Contacts

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