Capsule Extruder 2

Basic Information

• Brand Name: Capsule Extruder 2
• Primary DI: D010606065961
• Version / Model: 60606596
• Catalog Number: 60606596
• Company Name: Dentsply De Trey GmbH
• Labeler DUNS: 315471722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-16
• Public Version: 2
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 26f8325f-cd75-4a8a-96cb-fe2413accab8

Device Description

Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules

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: 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
KXR	APPLICATOR, RESIN	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	D010606065960	HIBCC
Primary	D010606065961	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	17.5	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius