Palodent® Plus Sectional Matrix System

Basic Information

Brand Name: Palodent® Plus Sectional Matrix System
Primary DI: D0026597001
Version / Model: 659700
Catalog Number: 659700
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: 2
Public Version Date: 2024-02-05
Public Version Status: Update
Public Device Record Key: e82c0638-e861-48dc-91be-fbee0ca8351f

Device Description

Palodent Plus Introductory 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: 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
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
31814	Dental dressing forceps, reusable	A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.	No	Active
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
35851	Rubber dam clamp forceps	A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.	No	Active
45007	Dental wedge, single-use	A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0026597001	HIBCC

Customer Contacts

Phone: +1(800)532-2855
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1x Universal Ring, 1x Narrow Ring, 25x Matrices each of 4 sizes, 25x Wedges each of 3 sizes, 10x WedgeGuards each of 3 sizes, 1x Forceps, 1x Pin Tweezers

Storage Conditions

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