LuxaPost

Basic Information

• Brand Name: LuxaPost
• Primary DI: EDMG1107820
• Version / Model: 110782
• Catalog Number: 110782
• 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: d42d363b-abc7-460f-8453-dc87d56643a9

Device Description

Glass fiber-reinforced pre-silanized composite root post. The DMG quality root post. Content: 5 posts (pre-silanized, Ø 1.375 mm ).

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
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EDMG1107821	HIBCC		1	In Commercial Distribution
Primary	EDMG1107820	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.375	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.