Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832MTXB2201
• Version / Model: MTXB2-20
• Catalog Number: MTXB2-20
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2023-06-06
• Public Version: 1
• Public Version Date: 2023-06-14
• Public Version Status: New
• Public Device Record Key: 19537ac4-5e1e-4bec-84c2-4dea4e84e144

Device Description

Tofflemire Matrix Bands, #2 Wide, 0.002" (0.05mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• 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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D832MTXB2200	HIBCC
Primary	D832MTXB2201	HIBCC