The Palodent® Sysetem Matrix System

Basic Information

• Brand Name: The Palodent® Sysetem Matrix System
• Primary DI: D002659060Y1
• Version / Model: 659060Y
• Catalog Number: 659060Y
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 1
• Public Version Date: 2019-04-10
• Public Version Status: New
• Public Device Record Key: 6595fdd4-cfdd-482a-bf0e-ac459c37faca

Device Description

Palodent Sectional Matrix System Complete Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	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
45008	Dental matrix band tensioner	A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D002659060Y1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			100x Standard Matrices, 50x Mini Matrices, 50x Plus Matrices, 4x BiTine® Round Rings, 2 BiTine® II Oval Rings

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Keep dry.