LuxaPost

Basic Information

• Brand Name: LuxaPost
• Primary DI: EDMG1107801
• Version / Model: 110780
• Catalog Number: 110780
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Labeler DUNS: 320744915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 1
• Public Version Date: 2022-09-09
• Public Version Status: New
• Public Device Record Key: 1f350ccc-d212-4547-8a1c-e75964d56f36

Device Description

Core-build-up and post cementation. Content: 5 posts Ø 1.25 mm, 5 posts Ø 1.375 mm, 5 posts Ø 1.5 mm, 1 drill Ø 1.25 mm, 1 drill Ø 1.375 mm, 1 drill Ø 1.5 mm, 30 silicone stops.

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELR	Post, Root Canal	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	EDMG1107800	HIBCC
Primary	EDMG1107801	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.25	Millimeter
Outer Diameter	1.375	Millimeter
Outer Diameter	1.5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Protect against chemical vapors.