Maquira

Basic Information

• Brand Name: Maquira
• Primary DI: 07898561541710
• Version / Model: Envelope containing 12 units of Airon Steel Abrasive Strip (6 mm)
• Catalog Number: 80322400077
• Company Name: Maquira Industria de Produtos Odontologicos S/A
• Labeler DUNS: 679266866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-07
• Public Version: 1
• Public Version Date: 2024-08-15
• Public Version Status: New
• Public Device Record Key: 46f7f60b-2fe7-4eb2-ab05-5c6ba524d4b3

Device Description

The Airon Steel Abrasive Strip has a mechanical operation, being composed of abrasive material that when entering in friction with the restored surface of the tooth promotes abrasion, wear and polishing of the treated region.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	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 the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898561541710	GS1