TOFFLEMIRE MATRIX BANDS X-THIN N.13

Basic Information

• Brand Name: TOFFLEMIRE MATRIX BANDS X-THIN N.13
• Primary DI: 07640159161950
• Version / Model: 41515
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-29
• Public Version: 1
• Public Version Date: 2022-07-07
• Public Version Status: New
• Public Device Record Key: e1489432-1585-4fbf-b084-c0493279a25c

Device Description

Tofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in combination with matrix retainers as part of contouring for restorative treatment. It enables to perform restoration with anatomic proximal contours and contact areas, by creating a temporary interproximal surface (contour). The different matrix bands provided by Produits Dentaires differ in geometry and size. All references exist in 2 different thickness: thin (0.05mm) and xthin (0.035mm). Tofflemire matrix retainers secure the appropriate matrix band in place Box of 12 bands - N°13 Adults

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYO	Band, Material, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640159161950	GS1

Customer Contacts

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