Palodent® 360 Circumferential Matrix System

Basic Information

• Brand Name: Palodent® 360 Circumferential Matrix System
• Primary DI: D002659605V1
• Version / Model: 659605V
• Catalog Number: 659605V
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-20
• Public Version: 1
• Public Version Date: 2022-09-28
• Public Version Status: New
• Public Device Record Key: 623f6f46-6a89-4689-a00d-f194dfbe9359

Device Description

Palodent® 360 Complete Kit Promo with Bonus

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D002659605V1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			72 Matrix Bands, 2 Rings, 100 Matrices, 75 Wedges, 30 WedgeGuards, 1 Forceps, 1 Pin Tweezers

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from moisture or excessive humidity.
• Type: Special Storage Condition, Specify
• Special Conditions: Store Palodent® 360 matrix bands at room temperature.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 36 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from flame or source of ignition.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of sunlight.