Maquira

Basic Information

• Brand Name: Maquira
• Primary DI: 07898561540270
• Version / Model: Box containing 150 units of Polyester Abrasive Strips Airon (4 x 170 mm)
• Catalog Number: 80322400058
• 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: d32e6a5d-60e7-468e-98e8-d4df2863a5fc

Device Description

The Polyester Abrasive Strips Airon aims at finishing and polishing of dental restorations. The functioning of the polyester sandpaper strip is mechanical, i.e. because it is composed of an abrasive material that when rubbing against the restored tooth surface, promotes abrasion/wear and polishing of the tooth 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	07898561540270	GS1