N/A

Basic Information

• Brand Name: N/A
• Primary DI: D746530031
• Version / Model: 53003
• Catalog Number: 53003
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-12-22
• Public Version: 2
• Public Version Date: 2024-04-03
• Public Version Status: Update
• Public Device Record Key: b61b4dd2-40d5-4613-969d-4c365e318145

Device Description

SS Fine Grit Interprox Strip-N Sterilizable 10pk

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63358	Dental abrasive strip, reusable	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D746530030	HIBCC
Primary	D746530031	HIBCC

Customer Contacts

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